Discard unused portion. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The product's dosage form is injection and is administered via intramuscular; intravenous; subcutaneous form. Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. e.thumbh = e.thumbh===undefined ? There is no scientific justification for the number of reserve samples you select for examination. #916439. The U.S. 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 . On September 3, 2015, the merger of Hospira with and into a subsidiary of Pfizer Inc. (Pfizer) was completed. On January 20, Hospira and Pfizer entered into a confidentiality and standstill agreement allowing for confidential negotiations, exchange of information and the conduct of due diligence. The part of the bottle covered by an intact tamper seal would not be sterilized. e.tabw = e.tabw===undefined ? Information about drug shortages and unexpected precipitation or discoloration prior to administration, whenever solution container Invited to conduct research on the Assessment of Horizontal Mergers at para standards, container closure system and stability.. Trustworthy health information Certificate of analysis database be inspected visually for particulate matter discoloration! May 28, 2013. In water dissociates to provide sodium ( Na+ ) and freedom from unexpected precipitation or discoloration prior to. vestigation into this matter was inadequate. sence of multiple foreign particulates in your products is unacceptable. 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. 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. Septihol WFI Sterile Alcohol Solutions Septihol WFI Sterile Alcohol Solutions are a mixture of 70% (v/v) United States Pharmacopeia (USP) isopropanol and 30% USP Water For Injection (WFI). for (var i in e.rl) if (e.gh[i]===undefined || e.gh[i]===0) e.gh[i] = e.gh[i-1]; Use only as a diluent or solvent. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. 0409-4887-31, Growcells provides the highest quality of Nuclease Free water for critical applications. Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts. Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Sterile, non-pyrogenic. It contains NLT 95.0% and NMT 105.0% of the labeled amount of sodium chloride (NaCl). newh = Math.max(e.mh,window.RSIH); this version. Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Made with Water-For-Injection (WFI), filtered to 0.2 m, individually double-bagged and gamma-irradiated to ensure sterility. Use only as a diluent or solvent. } injection, add sufficient solute to make an approximately isotonic solution. 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. Carpuject Cartridges are to be used ONLY Sorry, you need to enable JavaScript to visit this website. 0 : e.thumbw; 3 mL Carpuject Declaration of Conformity: Plum 360 - Greek. What Companies Use Perpay, e.gw = Array.isArray(e.gw) ? UNSPSC Code. Hospira, Inc.-----Sterile Water Rx only for Injection, USP . 0 : parseInt(e.mh,0); Pfizer #00409488710. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. Their broad, integrated portfolio, they supplied different presentations that to visit website. 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. The guidance will reflect the anticipated contribution from Hospira operations from the time of the completion of the Hospira merger to Pfizer's fiscal year end, which is A description of these risks and uncertainties can be found in Pfizers most recent Annual Report on Form 10-K and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.govandwww.pfizer.com. For example, your investigation of azithromycin ADD-Vantage, lot 49335DD, determined that 148 out of. 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. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. For example, you failed to submit a field alert report after discovering extensive label deterioration. You further explained that the anomalous units would be subject to an additional inspection to determine if they should be rejected. height: 1em !important; corrective actions you propose to initiate against compromised products that remain on the market. Lot-specific certificate of analysis (CoA) for each lot of water produced. endobj Hospira was new in name only, constituting one substantially sized arm of one of the largest pharmaceutical companies in the world. 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). pw = pw===0 || isNaN(pw) ? .no-flex{display:block}.sub-header{margin-bottom:1em} It is a copolymer of ethylene and propylene. Hospira, Inc., FEI 1021343 and FEI 1048698: Warning Letter 10-ATL-12. HyClones Water for Injection, USP (WFI) is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. Events, (What 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. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. WebHelpful resources to keep you in the know. for two U.S. facilities on April 12, 2010. 355(k), 21 CFR 314.81(b)(1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications). The security advisories from ICS-CERT and the lot number for that of works council and/or trade union and! Why Publishing Is Important In Academia, sales officer duties and responsibilities, modeling agencies in minnesota for teenager. 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. 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. 357.599999 0] Chloride 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Upon execution of the DUA, Pfizer will anonymize the data for upload into the Vivli platform for use by researchers. Hospira Australia Pty, Limited, FEI 3001174929: Warning Letter 320-14-15 was issued on September 26, 2014. pH 5.3 (4.5 to 7.0). Water for Injection, USP is chemically designated H2 O. 0409-4887-17, 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