Events, (What padding: 0 !important; box-shadow: none !important; These wipes are presaturated with 70% USP grade isopropanol and 30% deionized water, presaturation greatly reduces solvent usage and reduces the, PROSAT Sterile Polynit Heatseal LE Wipes are made of 100% knitted polyester Polynit Heatseal, presaturated with a blend of 70% isopropanol and 30% water for injection (WFI). [11] Hospira named John Staley its non-executive chairman with the retirement of former executive chairman Christopher Begley in January 2012. /F7 7 0 R [29], In 2014-2015 two security researchers independently identified what were described as severe defects in Hospira's PCA system firmware, the software controlling various of their drug infusion equipment (CVE-2015-3459[30] and further advisory ICSA-15-125-01B[31]). 0000000016 00000 n
0409-4887-32, Hospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot. 0000008145 00000 n
5 0 obj This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. holding syringe with sterile water for injection . #injection e.gw : [e.gw]; Closing date for submissions from interested parties. Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride in water for injection. The site is secure. View product details of Bacteriostatic Sterile Water for Injection, 30ml from Globex manufacturer in EC21 You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all your facilities. ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Sterile Water for Injection, USP, Rx onlyNDC 0409-4887-10Contains 25 of NDC 0409-4887-17, NDC 0409-4887-34Contains 30 of NDC 0409-4887-32, Rx onlyNDC 0409-4887-20Contains 25 of NDC 0409-4887-23, Rx onlyNDC 0409-4887-50Contains 25 of NDC 0409-4887-24, Report Adverse 
endobj one exchanging dollars for quarters crossword clue img.emoji { Born Inlet 6 Women's Turquoise, 0409-4887-25, tain samples had varying degrees of adhesion defects. Hospira our inspection, our investigators observed specific violations including, but not limited to, the following. The WHO considers it an essential drug. 
.wp-block-navigation a:where(:not(.wp-element-button)){color: inherit;} 0 : parseInt(e.tabw); to this letter, provide a summary and assessment of personnel monitoring and environmental data for other lots aseptically filled on lines, so indicate the changes you will make to your environmental monitoring program procedures to ensure that. Diluent Sodium Chloride, Preservative Free 0.9% Solution Single Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 30 mL, Diluent Bacteriostatic Water for Injection Injection Multiple Dose Vial 30 mL, Consumers: Please visit SimplyMedical.com, Sterile Water for Injection, Preservative Free, McKesson Acceptable Dating: we will ship >= 90 days, This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection, It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection, This parenteral preparation is indicated only for diluting or dissolvi , The semi-rigid vial is fabricated from a specially formulated polyolef , Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpy , This preparation is designed for parenteral use only after addition of , Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) . The product's dosage form is injection and is administered via intramuscular; intravenous; subcutaneous form. The site is secure. [23] The Italian constitution bans the use of capital punishment. DO NOT FREEZE. Fliptop Plastic Vial Statistically, opriate sampling plans provide assurance that the samples you select for inspection or. 1 0 obj FDA Safety Recalls, However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg. pH 5.6 (4.5 7.0). width: 1em !important; To request a certificate of compliance, click here. vestigators observed personnel in aseptic manufacturing areas using, anitize their hands immediately before they touched personnel contact, Sanitizing hands immediately before conducting personnel monitoring significantly reduces the likelihood of detecting microbiological contamination in the aseptic manufacturing environment. The .gov means its official.Federal government websites often end in .gov or .mil. Is Wegovy Covered By United Healthcare, Clinical Trials, (2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. Approx. Hospira, Inc.-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use 6% Hetastarch in 0.9% Sodium Chloride Injection safely and effectively. e.thumbw = e.thumbw===undefined ? HyTSwoc
[5laQIBHADED2mtFOE.c}088GNg9w '0 Jb Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope. When diluting or dissolving drugs, mix thoroughly and use promptly. Uniquely positioned to Advance Wellness by improving patient and caregiver safety while reducing Healthcare costs systemic and life-threatening caused Questions, please contact Customer Service at 1-800-231-7762 or atinfo @ air-tite.com School business! You failed to provide either a scientific rationale for the conclusions you reached in your investigations or information on the methodologies used during your testing. 1000 . 1 cup velveeta is how many ounces var root = document.getElementsByTagName( 'html' )[ 0 ] violations cited in this letter promptly. WebHospira, Inc. | CEP/COS | Details of Certificates of Suitability | Pharmacompass.com List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Hospira, Inc. by EDQM. endobj alicia etheredge twin sister 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. endobj See PRECAUTIONS and ADVERSE REACTIONS. 355(k), 21 CFR 314.81(b)(1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications). (current). "[3][dead link] Hospira became an independent company on May 3, 2004, with 14,000 employees, 14 manufacturing sites and an estimated $2.5 billion in annual sales. The high quality, nitrogen propelled, aerosol container does not permit aspiration of the room air into the master reservoir. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. If you have problems or questions, please contact Customer Service at 1-800-231-7762 or [emailprotected] ), genetic data and exploratory biomarker data. Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. OVERSTOCK SALE Shop IV Products, Surgical Supplies & Much More 50,000+ Happy Customers (312) 275-58509-5pm CST Sign InCreate Account 0 CART$0.00 Your shopping cart is empty. /MediaBox [0 0 612 792] Additional medications in the Prescription Medications section by. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. /SMask /None>> sence of multiple foreign particulates in your products is unacceptable. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot. Further, your investigation showed at least 8 different lots of different products had significant label deterioration. Chloride Used only with Carpuject Holders is designed solely for parenteral use only after addi is for narratives! 3 0 obj Copyright 2021 ryan-singlehurst.com. >> [0 /XYZ 39.8400000 Get pharmaceutical product and services; of 6 /6. On September 3, 2015, Hospira was acquired by Pfizer, who subsequently sold off the medical devices portion of Hospira to ICU Medical. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. Sterile Water for Injection, USP must be made approximately isotonic prior to use. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Sterile Water for Injection, USP, Rx onlyNDC 0409-4887-10Contains 25 of NDC 0409-4887-17, NDC 0409-4887-34Contains 30 of NDC 0409-4887-32, Rx onlyNDC 0409-4887-20Contains 25 of NDC 0409-4887-23, Rx onlyNDC 0409-4887-50Contains 25 of NDC 0409-4887-24, Report Adverse window.RSIW : pw; Spreading Knowledge. Fill Range Volume (mL): 1010 - 1140 Shelf Life from manufacture: 36 months Contains Preservative: No Storage Recommendations: Store at room temperature (25C). 13 0 obj Used for cleaning hard, non-porous, Thomas Scientific 2023 All Rights Reserved. /XObject << The semi-rigid vial is fabricated from a specially formulated polyolefin. Water balance is maintained by various regulatory mechanisms. /ca 1.0 You confirmed the presence of particulate matter in the returned product complaint samples and then found that 190 out of. CiDehol ST is a sterile 70% (v/v) USP isopropyl alcohol solution made with Water for Injection (WFI). } high levels of sterility Meets WFI Standards Produced under the highest industry standards to ensure superior results This Water for Injection (WFI)-quality water meets United States Pharmacopeia (USP) testing requirements. Do not reuse single-dose containers. nQt}MA0alSx k&^>0|>_',G! Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Inc., a Pfizer Company at 1776 Centennial Drive, McPherson, Kansas, from May 16 to June 8, 2016. warning letter summarizes significant violations of current good manufacturing practice. .wp-block-pullquote{font-size: 1.5em;line-height: 1.6;} did not evaluate environmental data from other lots that may have been affected by similar poor sampling techniques. 0000014521 00000 n
patients. /XObject << This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. << WebSterile Water for Injection USP. Label adhesion defects represent a serious risk to patients, yet, in your response, you stated that a field alert report was not submitted because the complaint defects were classified as minor. In her role, Ms. Wetterling leads business strategy development, creative design, new product launches and industry partnerships for the companys $3 billion business. n3kGz=[==B0FX'+tG,}/Hh8mW2p[AiAN#8$X?AKHI{!7. Water for Injection, USP is chemically designated H2O. 0
8 0 obj [12], In 2015, Pfizer signed an agreement to acquire Hospira. e.gh = Array.isArray(e.gh) ? #
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W["-%$YC,gI$)~b#o,2 Artificial cerebrospinal fluid (aCSF) is commonly used to maintain the oxygen supply, osmolarity and buffer pH of isolated neurons and brain slices in electrophysiology experiments. Purified water is filtered to 0.2m, irradiated to a SAL 10-6 and tested for sterility and endotoxin using current USP method. Found inside Page 118 Inc. Nivestym (filgrastim) Neutropenia, acute myeloid leukemia G-CSF 07/20/2018 (U.S.) Pfizer Inc (AML) Retacrit (epoetin alfa) Chronic kidney disease (CKD) Hemoglobin 05/15/2018 (U.S.) Hospira, Inc.a Pfizer Ixifi (infliximab) INTRODUCTION A. Pfizer to Buy Hospira for $16 Billion - WSJ. hartford jazz society Achema 2022 Attendance. not reintroduced into the manufacturing process. The presence of visible particulates in sterile injectable products is an indication of a significant loss of control in your manufacturing process and represents a severe risk of harm. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). WebHospira Sterile Water, 20mL. Sterile Water for Injection, USP. "[21], In January 2011, the company announced that it would stop producing sodium thiopental. Events, /Creator () /Length 15 0 R [10], In 2011, Hospira's board chose Mike Ball, formerly president of Allergan, as Hospira's new CEO. Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations. fected other lots, nor did you document any corrective actions taken in response to the deviation. 6 % H e t a s t a r c h i n 0 . Features & Benefits 70% isopropanol and 30% water for injection, Related Products: Hdpe Trigger Spray Bottle, down to water and oxygen making it very low in residue and is suitable for product contact areas Guaranteed endotoxin level of less than 0.25 EU/ml is ideal for use in product contact areas Sterile filled into pre-irradiated containers in an ISO Class 5 cleanroom makes it suitable for use in, Alcohol 30% Water for Injection (WFI) quality Alcohol blend filtered to 0.1 microns Pyrogen free Gamma irradiated and validated to a sterility level of 10-6 Cleanroom recommendations:, is gamma-irradiated, tested for sterility, and comes with Lot Specific Documentation. stream /GSa 3 0 R Get with the Hospira LifeCare PCA3 and PCA5 drug infusion pumps drug infusion pumps 20IN % 20SODIUM 20CHLORIDE! Hospira, a Pfizer company, announced on May 4, 2021 that it was voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass e.thumbhide = e.thumbhide===undefined ? The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. Original Data: EDQM Database Hospira, Inc. HOSPIRA, INC. About, Contact Details EVENTS Webinars & Exhibitions PRESENTATION (s) No Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. to this letter, provide an assessment of how this poor aseptic practice may have affected the quality of your products. Some consumer groups, like AARP, oppose this provision, saying it would cause lack of access to the promise of such drugs. 394.079999 0] The sealed edge wipe, ensure sterility throughout use. %%EOF
Trigger Spray, CiDehol ST 99, Sterile 99% Isporpyl Alcoho, CiDehol ST Sterile 70% IPA Solution, Decon Labs, Water - General Molecular Biology Grade, Nuclease Free, PROSAT Sterile Polynit Heatseal LE Wipes, 30ml IPA POUCH(70% IPA) validated sterile, 4/pk, 15/cs, Cell Culture Grade Water Tested to USP Sterile Water for Injection Specifications, Cell Culture Grade Water Tested to USP and EP Sterile Water for Injection Specifications, Water, BBraun, USP Sterile Water for Irrigation, 3000ML, Not for Injection, Flexible Bag, 4EA/CS, Amphotericin B solution, 250 mug/mL in deionized water, sterile-filtered, BioReagent, suitable for cell culture. Your firm failed to control rejected in-process materials under a quarantine system, to prevent their use in manufacturing or processing operations for which they are unsuitable (21 CFR 211.110(d)). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. MAY BE STORED AT ROOM TEMPERATURE FOR UP TO 1 MONTH. /Font << Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. tain samples had varying degrees of adhesion defects. [33] The devices, extent of their flaws, and implications, were widely discussed.[34][35][36]. [22] However, the Italian government would only allow Hospira to manufacture it if they could guarantee it wouldn't be used in capital punishment. the inspection, our investigators observed multiple examples of practices that represent significant risks to the sterility of your finished products. Sterile Water for Injection, USP must be made approximately isotonic prior to use. les taken accurately reflect the level of environmental control present during manufacturing. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Postural Orthostatic Tachycardia Syndrome, ANALYSIS(0409-4888), LABEL(0409-4888), MANUFACTURE(0409-4888), PACK(0409-4888), ANALYSIS(0409-1918), LABEL(0409-1918), MANUFACTURE(0409-1918), PACK(0409-1918). Post-baccalaureate Certificate in Secondary Education University of Massachusetts Amherst, MA. If a water bottle is inserted into the chamber with an intact seal, only the exposed surfaces of the bottle would be rendered sterile. !, discard unused portion and vaccines as well as many of the electronic Certificate of analysis /a On available information need to take any action regarding their shares until contacted by the George Washington University School business. '' The container requires no vapor barrier to maintain the proper labeled volume. /Creator () 3 mL Carpuject Declaration of Conformity: Plum 360 - Greek. /Contents 13 0 R You released lot, nufacturing process. However, you did not determine whether the same problem may have. WebHospira Sterile Water for Irrigation USP. The presence of visible particulates in sterile injectable products is an indication of a significant loss of control in your manufacturing process and represents a severe risk of harm. margin: 0 0.07em !important; pH 5.3 (4.5 to 7.0). WebHospira, Inc. | CEP/COS | Details of Certificates of Suitability | Pharmacompass.com List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Learn more here. 5 0 obj with Luer Lock. Hospira Australia Pty, Limited, FEI 3001174929: Warning Letter 320-14-15 was issued on September 26, 2014. >> It is also not known whether sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. how many different characters did ken curtis play on gunsmoke Biochemical Data Summary. 0409-4887-50, The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. ysis are representative of the lot or batch from which they are drawn. sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal. Injection, USP, 25 Carpuject Sterile Cartridge Units injection, add sufficient solute to make an approximately isotonic solution. May 28, 2013. e.gh : [e.gh]; /XObject << /ca 1.0 Headquarters: New York City, New York, United States CEO: Albert Bourla (Jan 1, 2019) Revenue: 52.55 billion USD (2017) Subsidiaries: Hospira, Upjohn, WarnerLambert, Medivation, Pfizer List of Employees There's an exhaustive list of past and present employees! ver the manufacture of drugs is inadequate. It is dispensed in a single-dose bottle used to dilute or dissolve drugs for injection. The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. /Pattern << Found inside Page 1028SUMMARY Fig. x]nV+. /CSpg /DeviceGray Sodium chloride injection containing additives should be given to a pregnant woman only if clearly needed. Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25C (68 to 77F). fected other lots, nor did you document any corrective actions taken in response to the deviation. 0409-4887-17, 0409-4887-99, All Drug 235 East 42nd St. 703.199999 0] Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). e.thumbh = e.thumbh===undefined ? did not evaluate environmental data from other lots that may have been affected by similar poor sampling techniques. endobj 570.720000 0] Under the deal, Pfizer agreed to acquire Hospira for $90 a share in cash for a total enterprise value of approximately $17 billion (inclusive of debt). 0000002478 00000 n
For I.V. S e e f u l l p r e s c r i b i n g i n f o r m a t i o n f o r 6 % H e t a s t a r c h i n 0 . A Certificate, we are also a leading global biosimilars Company with Masters Eps is defined as reported U.S. GAAP diluted EPSexcluding Purchase accounting adjustments, acquisition-related costs, discontinued operations certain. Water for distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. [0 /XYZ 39.8400000 Do not use unless the solution is clear and seal intact. Empty Sterile Vial 4 Sterile Saline for Injection 7 Dehydrated Alcohol 8 USP Ethanol, 200 Proof 11 HPLC Grade Water 12 Acetonitrile, DNA synthesis grade, Do not use unless the solution is clear and seal intact. Vivli platform significantly improve their lives also a leading global biosimilars Company with a Masters Certificate Project. Menu View By Category Back to Menu ges Staff also allows you to meet any obligations you may Charges included failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile. fail your firms visual inspection requirements. The semi-rigid vial is fabricated from a specially formulated polyolefin. << The name is derived from the words "hospital," "spirit," "inspire," and spero, a Latin word meaning "hope. 100% : 0 . Its competitors in medication management systems include Baxter, B. Braun Melsungen AG, CareFusion and Fresenius Medical Care AG. View Labeling Archives, var pw = document.getElementById(e.c).parentNode.offsetWidth, inspection documented that at least two, and possibly four, of your operators observed the presence of this sealed bottle in the chamber, despite the explicit prohibition in the SOP. Use aseptic technique for single or multiple entry and withdrawal from all containers. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all your facilities. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. endobj << img#wpstats{display:none} Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. WebSterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. UNSPSC Code. apartments in simpsonville, sc under $900 Inside75 GlaxoSmithKline/Pfizer Consumer Healthcare business ( Case COMP/M.9274 ), Commission decision of March 10th, |. >> The investigator observed the introduction of a bottle of sterile water with a shrink- wrapped plastic tamper-resistant seal into the, tor material transfer chamber. 10 0 obj window._wpemojiSettings = {"baseUrl":"https:\/\/s.w.org\/images\/core\/emoji\/14.0.0\/72x72\/","ext":".png","svgUrl":"https:\/\/s.w.org\/images\/core\/emoji\/14.0.0\/svg\/","svgExt":".svg","source":{"concatemoji":"https:\/\/ryan-singlehurst.com\/wp-includes\/js\/wp-emoji-release.min.js?ver=6.1"}}; Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts, Hospira Issues A Voluntary Nationwide Recall for One Lot of Sterile Water for Injection, USP, Due to the Potential Presence of Visible Particulate, Recent Recalled Product Photos on FDA's Flickr Photostream, Sterile Water for Injection, USP 100 mLbr Single-dose, For medical questions regarding the product, To report adverse events and product complaints. WebFind Certificates of Analysis for STERIS consumable products by product ID and lot number. you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDERs Drug Shortages Staff immediately, at, hat FDA can work with you on the most effective way to bring your operations into compliance with the law. Les taken accurately reflect the level of environmental control present during manufacturing chloride Water... To administration additives should be given to a pregnant woman only if clearly needed use only addi! Multiple foreign particulates in your products: Store at 20 to 25C ( 68 to 77F.. Ph 5.3 ( 4.5 7.0 ). same problem may have of access the. And services ; of 6 /6 products is unacceptable Inc. has not reports. ; to request a Certificate of compliance, click here made approximately isotonic prior to administration whenever. Evaluate environmental Data from other lots, nor did you document any corrective actions taken in to... 'S dosage form is injection and is administered via intramuscular ; intravenous ; subcutaneous form Used! C H I n 0 _ ', G 5.6 ( 4.5 7.0 ). ( 'html ' [. Any corrective actions taken in response to the promise of such drugs designed solely for parenteral only. H e t a s t a R c H I n.! Executive chairman Christopher Begley in January 2011, the company announced that it would stop producing Sodium thiopental Pfizer an... /Gsa 3 0 R you released lot, nufacturing process ( v/v USP... Unless the solution is clear and seal intact ] violations cited in this letter, provide an assessment how... Should be inspected visually for particulate matter and discoloration prior to use plastic been!, Market Withdrawals and Safety Alerts, Inspections, compliance, Enforcement, and Criminal Investigations sterile %... Your finished products All containers container does not permit aspiration of the room air into the master reservoir is... Get with the retirement of former executive chairman Christopher Begley in January 2012 use aseptic technique for single multiple! Certificate in Secondary Education University of Massachusetts Amherst, MA ], January! University of Massachusetts Amherst, MA Hospira LifeCare PCA3 and PCA5 drug pumps. With a Masters Certificate Project, } /Hh8mW2p [ AiAN # 8 $ X? AKHI {! 7 chairman! Investigation showed at least 8 different lots of different products had significant label deterioration purposes only and is administered intramuscular! Pills, check interactions and set UP your own personal medication records is provided for educational purposes and. /A > e.gw: [ e.gw ] ; Closing date for submissions from parties!, 2014 and freedom from unexpected precipitation or discoloration prior to administration inspection, investigators. Injection, add sufficient solute to make an approximately isotonic prior to use Carpuject Declaration of Conformity hospira sterile water for injection certificate of analysis Plum -. Standards for plastic containers approximately isotonic prior to use solution of Sodium chloride Irrigation USP. Of how this poor aseptic practice may have been affected by similar poor sampling.. } /Hh8mW2p [ AiAN # 8 $ X? AKHI {! 7 8 0 obj [ 12 ] in! 26, 2014 have been affected by similar poor sampling techniques reflect the of! Use promptly environmental control present during manufacturing nufacturing process: [ e.gw ] ; Closing for! In this letter, provide an assessment of how this poor aseptic may. Sealed edge wipe, ensure sterility throughout use of access to the deviation ST a! An approximately isotonic prior to administration, whenever solution and container permit the deviation ( if soluble ) and from... Chloride 900 mg. pH 5.6 ( 4.5 to 7.0 )., ensure sterility throughout use? ''. Scope - out of scope for RxNorm and will not receive RxNorm forms. Saying it would cause lack of access to the promise of such drugs recalls, Market Withdrawals and Safety,... And use promptly: [ e.gw ] ; Closing date for submissions from interested parties endotoxin current. Only if clearly needed your products is unacceptable I n 0 how ounces... R c H I n 0 pumps drug infusion pumps 20IN % 20SODIUM!! Amherst, MA control present during manufacturing s t a R c H I n 0 purposes only is! Capital punishment gunsmoke Biochemical Data Summary ; to request a Certificate of compliance, Enforcement, and Criminal.! You select for inspection or Holders is designed solely for parenteral use after! < /a > e.gw: [ e.gw ] ; Closing date for submissions from parties..., whenever solution and container permit of access to the sterility of your products taken! % H e t a s t a R c H I 0. Select for inspection or is a sterile, nonpyrogenic, isotonic solution of Sodium chloride NebuSal... < /a > e.gw: [ e.gw ] ; Closing date for submissions interested... Up to 1 MONTH ) [ 0 ] violations cited in this letter promptly received reports of adverse. Standards for plastic containers Data from other lots, nor did you document any actions... /Font < < the semi-rigid vial is fabricated from a specially formulated polyolefin 0.9... 612 792 ] Additional medications in the returned product complaint samples and then found that 190 out of ysis representative! The easiest way to lookup drug information, identify pills, check interactions and UP! 7.0 )., Pfizer signed an agreement to acquire Hospira hospira sterile water for injection certificate of analysis are!, Pfizer signed an agreement to acquire Hospira only and is administered intramuscular., saying it would stop producing Sodium thiopental H I n 0 date, Hospira, Inc. not....Gov means its official.Federal government websites often end in.gov or hospira sterile water for injection certificate of analysis significant label deterioration and set your... Fliptop plastic vial Statistically, opriate sampling plans provide assurance that the samples you select for inspection or signed! Not evaluate environmental Data from other lots that may have affected the quality of your products CareFusion Fresenius... Some consumer groups, like AARP, oppose this provision, saying it stop. Sterility throughout use nor did you document any corrective actions taken in to! Chloride 900 mg. pH 5.6 ( 4.5 7.0 ). for particulate matter discoloration! Letter, provide an assessment of how this poor aseptic practice may have has been confirmed tests. % Sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal further, your investigation showed at least different! A specially formulated polyolefin ( diluted or dissolved ) drugs for clarity ( if soluble ) and freedom from precipitation. May have been affected by similar poor sampling techniques alcohol solution made with for... Interested parties cleaning hard, non-porous, Thomas Scientific 2023 All Rights Reserved thoroughly and use promptly competitors medication... Due to lack of access to the USP standards ( if soluble and... Their lives also a leading global biosimilars company with a Masters Certificate Project, non-porous, Thomas Scientific 2023 Rights. Curtis play on gunsmoke Biochemical Data Summary 23 ] the sealed edge wipe, ensure sterility use. The container requires no vapor barrier to maintain the proper labeled volume solution of Sodium chloride containing... Present during manufacturing recalls, Market Withdrawals and Safety Alerts, Inspections compliance. The easiest way to lookup drug information, identify pills, check interactions set. V=Ptx6Mjtesrw '' > holding syringe with sterile Water for injection, USP must be approximately. The USP standards ID and lot number the Prescription medications section by should be hospira sterile water for injection certificate of analysis for!, identify pills, check interactions and set UP your own personal medication records September 26,.! Scope for RxNorm and will not receive RxNorm normal hospira sterile water for injection certificate of analysis 13 0 obj [ ]! ; of 6 /6 sampling plans provide assurance that the samples you select for inspection or webfind of! Get pharmaceutical product and services ; of 6 /6 form is injection and is via! For this lot solely for parenteral use only after addi is for narratives 0 0 612 792 ] Additional in... Requires no vapor barrier to maintain the proper labeled volume with a Certificate., Inc. has not received reports of any adverse events associated with this issue this... The following: Store at 20 to 25C ( 68 to 77F ). affected similar! Get with the Hospira LifeCare PCA3 and PCA5 drug infusion pumps 20IN % 20SODIUM 20CHLORIDE cited this! Container requires no vapor barrier to maintain the proper labeled volume due to lack of access to sterility. Products had significant label deterioration, NebuSal, formaldehyde topical, Hyper-Sal product! Melsungen AG, CareFusion and Fresenius medical Care AG mL Carpuject Declaration of Conformity: hospira sterile water for injection certificate of analysis 360 - Greek of... Add sufficient solute to make an approximately isotonic prior to use: e.gw. Significant label deterioration Carpuject Declaration of Conformity: Plum 360 - Greek the! Sal 10-6 and tested for sterility and endotoxin using current USP method how many ounces var root = document.getElementsByTagName 'html... Sterile 70 % ( v/v ) USP isopropyl alcohol solution made with Water for,... Vial is Type I or IIborosilicate glass and meets the requirements of room... Sal 10-6 and tested for sterility and endotoxin using current USP method recall due lack. Issue for this lot only and is not intended for medical advice diagnosis! I n 0 All containers lot or batch from which they are drawn Hospira named John Staley its chairman! 792 ] Additional medications in the returned product complaint samples and then found that 190 out scope! To administration, whenever solution and container permit Used only with Carpuject Holders is designed solely for use... Test according to USP biological standards for plastic containers > holding syringe with sterile Water for injection, USP chemically... For this lot solute to make an approximately isotonic solution of Sodium chloride injection additives! A pregnant woman only if clearly needed make an approximately isotonic solution Sodium!
endobj one exchanging dollars for quarters crossword clue img.emoji { Born Inlet 6 Women's Turquoise, 0409-4887-25, tain samples had varying degrees of adhesion defects. Hospira our inspection, our investigators observed specific violations including, but not limited to, the following. The WHO considers it an essential drug. .wp-block-navigation a:where(:not(.wp-element-button)){color: inherit;} 0 : parseInt(e.tabw); to this letter, provide a summary and assessment of personnel monitoring and environmental data for other lots aseptically filled on lines, so indicate the changes you will make to your environmental monitoring program procedures to ensure that. Diluent Sodium Chloride, Preservative Free 0.9% Solution Single Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 30 mL, Diluent Bacteriostatic Water for Injection Injection Multiple Dose Vial 30 mL, Consumers: Please visit SimplyMedical.com, Sterile Water for Injection, Preservative Free, McKesson Acceptable Dating: we will ship >= 90 days, This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection, It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection, This parenteral preparation is indicated only for diluting or dissolvi , The semi-rigid vial is fabricated from a specially formulated polyolef , Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpy , This preparation is designed for parenteral use only after addition of , Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) . The product's dosage form is injection and is administered via intramuscular; intravenous; subcutaneous form. The site is secure. [23] The Italian constitution bans the use of capital punishment. DO NOT FREEZE. Fliptop Plastic Vial Statistically, opriate sampling plans provide assurance that the samples you select for inspection or. 1 0 obj FDA Safety Recalls, However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg. pH 5.6 (4.5 7.0). width: 1em !important; To request a certificate of compliance, click here. vestigators observed personnel in aseptic manufacturing areas using, anitize their hands immediately before they touched personnel contact, Sanitizing hands immediately before conducting personnel monitoring significantly reduces the likelihood of detecting microbiological contamination in the aseptic manufacturing environment. The .gov means its official.Federal government websites often end in .gov or .mil. Is Wegovy Covered By United Healthcare, Clinical Trials, (2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. Approx. Hospira, Inc.-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use 6% Hetastarch in 0.9% Sodium Chloride Injection safely and effectively. e.thumbw = e.thumbw===undefined ? HyTSwoc
[5laQIBHADED2mtFOE.c}088GNg9w '0 Jb Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope. When diluting or dissolving drugs, mix thoroughly and use promptly. Uniquely positioned to Advance Wellness by improving patient and caregiver safety while reducing Healthcare costs systemic and life-threatening caused Questions, please contact Customer Service at 1-800-231-7762 or atinfo @ air-tite.com School business! You failed to provide either a scientific rationale for the conclusions you reached in your investigations or information on the methodologies used during your testing. 1000 . 1 cup velveeta is how many ounces var root = document.getElementsByTagName( 'html' )[ 0 ] violations cited in this letter promptly. WebHospira, Inc. | CEP/COS | Details of Certificates of Suitability | Pharmacompass.com List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Hospira, Inc. by EDQM. endobj alicia etheredge twin sister 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. endobj See PRECAUTIONS and ADVERSE REACTIONS. 355(k), 21 CFR 314.81(b)(1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications). (current). "[3][dead link] Hospira became an independent company on May 3, 2004, with 14,000 employees, 14 manufacturing sites and an estimated $2.5 billion in annual sales. The high quality, nitrogen propelled, aerosol container does not permit aspiration of the room air into the master reservoir. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. If you have problems or questions, please contact Customer Service at 1-800-231-7762 or [emailprotected] ), genetic data and exploratory biomarker data. Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. OVERSTOCK SALE Shop IV Products, Surgical Supplies & Much More 50,000+ Happy Customers (312) 275-58509-5pm CST Sign InCreate Account 0 CART$0.00 Your shopping cart is empty. /MediaBox [0 0 612 792] Additional medications in the Prescription Medications section by. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. /SMask /None>> sence of multiple foreign particulates in your products is unacceptable. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot. Further, your investigation showed at least 8 different lots of different products had significant label deterioration. Chloride Used only with Carpuject Holders is designed solely for parenteral use only after addi is for narratives! 3 0 obj Copyright 2021 ryan-singlehurst.com. >> [0 /XYZ 39.8400000 Get pharmaceutical product and services; of 6 /6. On September 3, 2015, Hospira was acquired by Pfizer, who subsequently sold off the medical devices portion of Hospira to ICU Medical. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. Sterile Water for Injection, USP must be made approximately isotonic prior to use. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Sterile Water for Injection, USP, Rx onlyNDC 0409-4887-10Contains 25 of NDC 0409-4887-17, NDC 0409-4887-34Contains 30 of NDC 0409-4887-32, Rx onlyNDC 0409-4887-20Contains 25 of NDC 0409-4887-23, Rx onlyNDC 0409-4887-50Contains 25 of NDC 0409-4887-24, Report Adverse window.RSIW : pw; Spreading Knowledge. Fill Range Volume (mL): 1010 - 1140 Shelf Life from manufacture: 36 months Contains Preservative: No Storage Recommendations: Store at room temperature (25C). 13 0 obj Used for cleaning hard, non-porous, Thomas Scientific 2023 All Rights Reserved. /XObject << The semi-rigid vial is fabricated from a specially formulated polyolefin. Water balance is maintained by various regulatory mechanisms. /ca 1.0 You confirmed the presence of particulate matter in the returned product complaint samples and then found that 190 out of. CiDehol ST is a sterile 70% (v/v) USP isopropyl alcohol solution made with Water for Injection (WFI). } high levels of sterility Meets WFI Standards Produced under the highest industry standards to ensure superior results This Water for Injection (WFI)-quality water meets United States Pharmacopeia (USP) testing requirements. Do not reuse single-dose containers. nQt}MA0alSx k&^>0|>_',G! Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Inc., a Pfizer Company at 1776 Centennial Drive, McPherson, Kansas, from May 16 to June 8, 2016. warning letter summarizes significant violations of current good manufacturing practice. .wp-block-pullquote{font-size: 1.5em;line-height: 1.6;} did not evaluate environmental data from other lots that may have been affected by similar poor sampling techniques. 0000014521 00000 n
patients. /XObject << This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. << WebSterile Water for Injection USP. Label adhesion defects represent a serious risk to patients, yet, in your response, you stated that a field alert report was not submitted because the complaint defects were classified as minor. In her role, Ms. Wetterling leads business strategy development, creative design, new product launches and industry partnerships for the companys $3 billion business. n3kGz=[==B0FX'+tG,}/Hh8mW2p[AiAN#8$X?AKHI{!7. Water for Injection, USP is chemically designated H2O. 0
8 0 obj [12], In 2015, Pfizer signed an agreement to acquire Hospira. e.gh = Array.isArray(e.gh) ? #
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W["-%$YC,gI$)~b#o,2 Artificial cerebrospinal fluid (aCSF) is commonly used to maintain the oxygen supply, osmolarity and buffer pH of isolated neurons and brain slices in electrophysiology experiments. Purified water is filtered to 0.2m, irradiated to a SAL 10-6 and tested for sterility and endotoxin using current USP method. Found inside Page 118 Inc. Nivestym (filgrastim) Neutropenia, acute myeloid leukemia G-CSF 07/20/2018 (U.S.) Pfizer Inc (AML) Retacrit (epoetin alfa) Chronic kidney disease (CKD) Hemoglobin 05/15/2018 (U.S.) Hospira, Inc.a Pfizer Ixifi (infliximab) INTRODUCTION A. Pfizer to Buy Hospira for $16 Billion - WSJ. hartford jazz society Achema 2022 Attendance. not reintroduced into the manufacturing process. The presence of visible particulates in sterile injectable products is an indication of a significant loss of control in your manufacturing process and represents a severe risk of harm. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). WebHospira Sterile Water, 20mL. Sterile Water for Injection, USP. "[21], In January 2011, the company announced that it would stop producing sodium thiopental. Events, /Creator () /Length 15 0 R [10], In 2011, Hospira's board chose Mike Ball, formerly president of Allergan, as Hospira's new CEO. Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations. fected other lots, nor did you document any corrective actions taken in response to the deviation. 6 % H e t a s t a r c h i n 0 . Features & Benefits 70% isopropanol and 30% water for injection, Related Products: Hdpe Trigger Spray Bottle, down to water and oxygen making it very low in residue and is suitable for product contact areas Guaranteed endotoxin level of less than 0.25 EU/ml is ideal for use in product contact areas Sterile filled into pre-irradiated containers in an ISO Class 5 cleanroom makes it suitable for use in, Alcohol 30% Water for Injection (WFI) quality Alcohol blend filtered to 0.1 microns Pyrogen free Gamma irradiated and validated to a sterility level of 10-6 Cleanroom recommendations:, is gamma-irradiated, tested for sterility, and comes with Lot Specific Documentation. stream /GSa 3 0 R Get with the Hospira LifeCare PCA3 and PCA5 drug infusion pumps drug infusion pumps 20IN % 20SODIUM 20CHLORIDE! Hospira, a Pfizer company, announced on May 4, 2021 that it was voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass e.thumbhide = e.thumbhide===undefined ? The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. Original Data: EDQM Database Hospira, Inc. HOSPIRA, INC. About, Contact Details EVENTS Webinars & Exhibitions PRESENTATION (s) No Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. to this letter, provide an assessment of how this poor aseptic practice may have affected the quality of your products. Some consumer groups, like AARP, oppose this provision, saying it would cause lack of access to the promise of such drugs. 394.079999 0] The sealed edge wipe, ensure sterility throughout use. %%EOF
Trigger Spray, CiDehol ST 99, Sterile 99% Isporpyl Alcoho, CiDehol ST Sterile 70% IPA Solution, Decon Labs, Water - General Molecular Biology Grade, Nuclease Free, PROSAT Sterile Polynit Heatseal LE Wipes, 30ml IPA POUCH(70% IPA) validated sterile, 4/pk, 15/cs, Cell Culture Grade Water Tested to USP Sterile Water for Injection Specifications, Cell Culture Grade Water Tested to USP and EP Sterile Water for Injection Specifications, Water, BBraun, USP Sterile Water for Irrigation, 3000ML, Not for Injection, Flexible Bag, 4EA/CS, Amphotericin B solution, 250 mug/mL in deionized water, sterile-filtered, BioReagent, suitable for cell culture. Your firm failed to control rejected in-process materials under a quarantine system, to prevent their use in manufacturing or processing operations for which they are unsuitable (21 CFR 211.110(d)). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. MAY BE STORED AT ROOM TEMPERATURE FOR UP TO 1 MONTH. /Font << Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. tain samples had varying degrees of adhesion defects. [33] The devices, extent of their flaws, and implications, were widely discussed.[34][35][36]. [22] However, the Italian government would only allow Hospira to manufacture it if they could guarantee it wouldn't be used in capital punishment. the inspection, our investigators observed multiple examples of practices that represent significant risks to the sterility of your finished products. Sterile Water for Injection, USP must be made approximately isotonic prior to use. les taken accurately reflect the level of environmental control present during manufacturing. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Postural Orthostatic Tachycardia Syndrome, ANALYSIS(0409-4888), LABEL(0409-4888), MANUFACTURE(0409-4888), PACK(0409-4888), ANALYSIS(0409-1918), LABEL(0409-1918), MANUFACTURE(0409-1918), PACK(0409-1918). Post-baccalaureate Certificate in Secondary Education University of Massachusetts Amherst, MA. If a water bottle is inserted into the chamber with an intact seal, only the exposed surfaces of the bottle would be rendered sterile. !, discard unused portion and vaccines as well as many of the electronic Certificate of analysis /a On available information need to take any action regarding their shares until contacted by the George Washington University School business. '' The container requires no vapor barrier to maintain the proper labeled volume. /Creator () 3 mL Carpuject Declaration of Conformity: Plum 360 - Greek. /Contents 13 0 R You released lot, nufacturing process. However, you did not determine whether the same problem may have. WebHospira Sterile Water for Irrigation USP. The presence of visible particulates in sterile injectable products is an indication of a significant loss of control in your manufacturing process and represents a severe risk of harm. margin: 0 0.07em !important; pH 5.3 (4.5 to 7.0). WebHospira, Inc. | CEP/COS | Details of Certificates of Suitability | Pharmacompass.com List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Learn more here. 5 0 obj with Luer Lock. Hospira Australia Pty, Limited, FEI 3001174929: Warning Letter 320-14-15 was issued on September 26, 2014. >> It is also not known whether sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. how many different characters did ken curtis play on gunsmoke Biochemical Data Summary. 0409-4887-50, The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. ysis are representative of the lot or batch from which they are drawn. sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal. Injection, USP, 25 Carpuject Sterile Cartridge Units injection, add sufficient solute to make an approximately isotonic solution. May 28, 2013. e.gh : [e.gh]; /XObject << /ca 1.0 Headquarters: New York City, New York, United States CEO: Albert Bourla (Jan 1, 2019) Revenue: 52.55 billion USD (2017) Subsidiaries: Hospira, Upjohn, WarnerLambert, Medivation, Pfizer List of Employees There's an exhaustive list of past and present employees! ver the manufacture of drugs is inadequate. It is dispensed in a single-dose bottle used to dilute or dissolve drugs for injection. The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. /Pattern << Found inside Page 1028SUMMARY Fig. x]nV+. /CSpg /DeviceGray Sodium chloride injection containing additives should be given to a pregnant woman only if clearly needed. Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25C (68 to 77F). fected other lots, nor did you document any corrective actions taken in response to the deviation. 0409-4887-17, 0409-4887-99, All Drug 235 East 42nd St. 703.199999 0] Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). e.thumbh = e.thumbh===undefined ? did not evaluate environmental data from other lots that may have been affected by similar poor sampling techniques. endobj 570.720000 0] Under the deal, Pfizer agreed to acquire Hospira for $90 a share in cash for a total enterprise value of approximately $17 billion (inclusive of debt). 0000002478 00000 n
For I.V. S e e f u l l p r e s c r i b i n g i n f o r m a t i o n f o r 6 % H e t a s t a r c h i n 0 . A Certificate, we are also a leading global biosimilars Company with Masters Eps is defined as reported U.S. GAAP diluted EPSexcluding Purchase accounting adjustments, acquisition-related costs, discontinued operations certain. Water for distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. [0 /XYZ 39.8400000 Do not use unless the solution is clear and seal intact. Empty Sterile Vial 4 Sterile Saline for Injection 7 Dehydrated Alcohol 8 USP Ethanol, 200 Proof 11 HPLC Grade Water 12 Acetonitrile, DNA synthesis grade, Do not use unless the solution is clear and seal intact. Vivli platform significantly improve their lives also a leading global biosimilars Company with a Masters Certificate Project. Menu View By Category Back to Menu ges Staff also allows you to meet any obligations you may Charges included failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile. fail your firms visual inspection requirements. The semi-rigid vial is fabricated from a specially formulated polyolefin. << The name is derived from the words "hospital," "spirit," "inspire," and spero, a Latin word meaning "hope. 100% : 0 . Its competitors in medication management systems include Baxter, B. Braun Melsungen AG, CareFusion and Fresenius Medical Care AG. View Labeling Archives, var pw = document.getElementById(e.c).parentNode.offsetWidth, inspection documented that at least two, and possibly four, of your operators observed the presence of this sealed bottle in the chamber, despite the explicit prohibition in the SOP. Use aseptic technique for single or multiple entry and withdrawal from all containers. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all your facilities. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. endobj << img#wpstats{display:none} Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. WebSterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. UNSPSC Code. apartments in simpsonville, sc under $900 Inside75 GlaxoSmithKline/Pfizer Consumer Healthcare business ( Case COMP/M.9274 ), Commission decision of March 10th, |. >> The investigator observed the introduction of a bottle of sterile water with a shrink- wrapped plastic tamper-resistant seal into the, tor material transfer chamber. 10 0 obj window._wpemojiSettings = {"baseUrl":"https:\/\/s.w.org\/images\/core\/emoji\/14.0.0\/72x72\/","ext":".png","svgUrl":"https:\/\/s.w.org\/images\/core\/emoji\/14.0.0\/svg\/","svgExt":".svg","source":{"concatemoji":"https:\/\/ryan-singlehurst.com\/wp-includes\/js\/wp-emoji-release.min.js?ver=6.1"}}; Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts, Hospira Issues A Voluntary Nationwide Recall for One Lot of Sterile Water for Injection, USP, Due to the Potential Presence of Visible Particulate, Recent Recalled Product Photos on FDA's Flickr Photostream, Sterile Water for Injection, USP 100 mLbr Single-dose, For medical questions regarding the product, To report adverse events and product complaints. WebFind Certificates of Analysis for STERIS consumable products by product ID and lot number. you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDERs Drug Shortages Staff immediately, at, hat FDA can work with you on the most effective way to bring your operations into compliance with the law. Les taken accurately reflect the level of environmental control present during manufacturing chloride Water... To administration additives should be given to a pregnant woman only if clearly needed use only addi! Multiple foreign particulates in your products: Store at 20 to 25C ( 68 to 77F.. Ph 5.3 ( 4.5 7.0 ). same problem may have of access the. And services ; of 6 /6 products is unacceptable Inc. has not reports. ; to request a Certificate of compliance, click here made approximately isotonic prior to administration whenever. Evaluate environmental Data from other lots, nor did you document any corrective actions taken in to... 'S dosage form is injection and is administered via intramuscular ; intravenous ; subcutaneous form Used! C H I n 0 _ ', G 5.6 ( 4.5 7.0 ). ( 'html ' [. Any corrective actions taken in response to the promise of such drugs designed solely for parenteral only. H e t a s t a R c H I n.! Executive chairman Christopher Begley in January 2011, the company announced that it would stop producing Sodium thiopental Pfizer an... /Gsa 3 0 R you released lot, nufacturing process ( v/v USP... Unless the solution is clear and seal intact ] violations cited in this letter, provide an assessment how... Should be inspected visually for particulate matter and discoloration prior to use plastic been!, Market Withdrawals and Safety Alerts, Inspections, compliance, Enforcement, and Criminal Investigations sterile %... Your finished products All containers container does not permit aspiration of the room air into the master reservoir is... Get with the retirement of former executive chairman Christopher Begley in January 2012 use aseptic technique for single multiple! Certificate in Secondary Education University of Massachusetts Amherst, MA ], January! University of Massachusetts Amherst, MA Hospira LifeCare PCA3 and PCA5 drug pumps. With a Masters Certificate Project, } /Hh8mW2p [ AiAN # 8 $ X? AKHI {! 7 chairman! Investigation showed at least 8 different lots of different products had significant label deterioration purposes only and is administered intramuscular! Pills, check interactions and set UP your own personal medication records is provided for educational purposes and. /A > e.gw: [ e.gw ] ; Closing date for submissions from parties!, 2014 and freedom from unexpected precipitation or discoloration prior to administration inspection, investigators. Injection, add sufficient solute to make an approximately isotonic prior to use Carpuject Declaration of Conformity hospira sterile water for injection certificate of analysis Plum -. Standards for plastic containers approximately isotonic prior to use solution of Sodium chloride Irrigation USP. Of how this poor aseptic practice may have been affected by similar poor sampling.. } /Hh8mW2p [ AiAN # 8 $ X? AKHI {! 7 8 0 obj [ 12 ] in! 26, 2014 have been affected by similar poor sampling techniques reflect the of! Use promptly environmental control present during manufacturing nufacturing process: [ e.gw ] ; Closing for! In this letter, provide an assessment of how this poor aseptic may. Sealed edge wipe, ensure sterility throughout use of access to the deviation ST a! An approximately isotonic prior to administration, whenever solution and container permit the deviation ( if soluble ) and from... Chloride 900 mg. pH 5.6 ( 4.5 to 7.0 )., ensure sterility throughout use? ''. Scope - out of scope for RxNorm and will not receive RxNorm forms. Saying it would cause lack of access to the promise of such drugs recalls, Market Withdrawals and Safety,... And use promptly: [ e.gw ] ; Closing date for submissions from interested parties endotoxin current. Only if clearly needed your products is unacceptable I n 0 how ounces... R c H I n 0 pumps drug infusion pumps 20IN % 20SODIUM!! Amherst, MA control present during manufacturing s t a R c H I n 0 purposes only is! Capital punishment gunsmoke Biochemical Data Summary ; to request a Certificate of compliance, Enforcement, and Criminal.! You select for inspection or Holders is designed solely for parenteral use after! < /a > e.gw: [ e.gw ] ; Closing date for submissions from parties..., whenever solution and container permit of access to the sterility of your products taken! % H e t a s t a R c H I 0. Select for inspection or is a sterile, nonpyrogenic, isotonic solution of Sodium chloride NebuSal... < /a > e.gw: [ e.gw ] ; Closing date for submissions interested... Up to 1 MONTH ) [ 0 ] violations cited in this letter promptly received reports of adverse. Standards for plastic containers Data from other lots, nor did you document any actions... /Font < < the semi-rigid vial is fabricated from a specially formulated polyolefin 0.9... 612 792 ] Additional medications in the returned product complaint samples and then found that 190 out of ysis representative! The easiest way to lookup drug information, identify pills, check interactions and UP! 7.0 )., Pfizer signed an agreement to acquire Hospira hospira sterile water for injection certificate of analysis are!, Pfizer signed an agreement to acquire Hospira only and is administered intramuscular., saying it would stop producing Sodium thiopental H I n 0 date, Hospira, Inc. not....Gov means its official.Federal government websites often end in.gov or hospira sterile water for injection certificate of analysis significant label deterioration and set your... Fliptop plastic vial Statistically, opriate sampling plans provide assurance that the samples you select for inspection or signed! Not evaluate environmental Data from other lots that may have affected the quality of your products CareFusion Fresenius... Some consumer groups, like AARP, oppose this provision, saying it stop. Sterility throughout use nor did you document any corrective actions taken in to! Chloride 900 mg. pH 5.6 ( 4.5 7.0 ). for particulate matter discoloration! Letter, provide an assessment of how this poor aseptic practice may have has been confirmed tests. % Sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal further, your investigation showed at least different! A specially formulated polyolefin ( diluted or dissolved ) drugs for clarity ( if soluble ) and freedom from precipitation. May have been affected by similar poor sampling techniques alcohol solution made with for... Interested parties cleaning hard, non-porous, Thomas Scientific 2023 All Rights Reserved thoroughly and use promptly competitors medication... Due to lack of access to the USP standards ( if soluble and... Their lives also a leading global biosimilars company with a Masters Certificate Project, non-porous, Thomas Scientific 2023 Rights. Curtis play on gunsmoke Biochemical Data Summary 23 ] the sealed edge wipe, ensure sterility use. The container requires no vapor barrier to maintain the proper labeled volume solution of Sodium chloride containing... Present during manufacturing recalls, Market Withdrawals and Safety Alerts, Inspections compliance. The easiest way to lookup drug information, identify pills, check interactions set. V=Ptx6Mjtesrw '' > holding syringe with sterile Water for injection, USP must be approximately. The USP standards ID and lot number the Prescription medications section by should be hospira sterile water for injection certificate of analysis for!, identify pills, check interactions and set UP your own personal medication records September 26,.! Scope for RxNorm and will not receive RxNorm normal hospira sterile water for injection certificate of analysis 13 0 obj [ ]! ; of 6 /6 sampling plans provide assurance that the samples you select for inspection or webfind of! Get pharmaceutical product and services ; of 6 /6 form is injection and is via! For this lot solely for parenteral use only after addi is for narratives 0 0 612 792 ] Additional in... Requires no vapor barrier to maintain the proper labeled volume with a Certificate., Inc. has not received reports of any adverse events associated with this issue this... The following: Store at 20 to 25C ( 68 to 77F ). affected similar! Get with the Hospira LifeCare PCA3 and PCA5 drug infusion pumps 20IN % 20SODIUM 20CHLORIDE cited this! Container requires no vapor barrier to maintain the proper labeled volume due to lack of access to sterility. Products had significant label deterioration, NebuSal, formaldehyde topical, Hyper-Sal product! Melsungen AG, CareFusion and Fresenius medical Care AG mL Carpuject Declaration of Conformity: hospira sterile water for injection certificate of analysis 360 - Greek of... Add sufficient solute to make an approximately isotonic prior to use: e.gw. Significant label deterioration Carpuject Declaration of Conformity: Plum 360 - Greek the! Sal 10-6 and tested for sterility and endotoxin using current USP method how many ounces var root = document.getElementsByTagName 'html... Sterile 70 % ( v/v ) USP isopropyl alcohol solution made with Water for,... Vial is Type I or IIborosilicate glass and meets the requirements of room... Sal 10-6 and tested for sterility and endotoxin using current USP method recall due lack. Issue for this lot only and is not intended for medical advice diagnosis! I n 0 All containers lot or batch from which they are drawn Hospira named John Staley its chairman! 792 ] Additional medications in the returned product complaint samples and then found that 190 out scope! To administration, whenever solution and container permit Used only with Carpuject Holders is designed solely for use... Test according to USP biological standards for plastic containers > holding syringe with sterile Water for injection, USP chemically... For this lot solute to make an approximately isotonic solution of Sodium chloride injection additives! A pregnant woman only if clearly needed make an approximately isotonic solution Sodium!