hospira sterile water for injection certificate of analysishospira sterile water for injection certificate of analysis

corrective actions you propose to initiate against compromised products that remain on the market. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. Charges included failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile. Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. 9 % S o d i u m C h l o r i d e I n j e c t i o n , f o r i n t r a v e n o u s u s e I n i t i a l U . WebHyClones Water for Injection, USP (WFI) is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. our inspection, we reviewed reports from multiple investigations that you conducted into complaints regarding the presence of visible particulates in several of your sterile injectable products. Vial is fabricated from a specially formulated polyolefin health care products their shares contacted! Pagerank Matrix Formulation, 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. The site is secure. Biochemical Data Summary. ET, Monday through Friday. Suppliers of heparin IV, they are uniquely positioned to Advance Wellness by improving and. endobj There was only one other credible competitor in the relevant market, according to the assessment of the European Be the first to review this product. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all your facilities. HyClones Water for Injection, USP (WFI) is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. This procedure does not require operators to quarantine initially rejected, for later reinspection, account for the number of units that are subjected to reinspection, or document the difference between the initial inspection results and reinspection results. 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. Assessed and authorised under Regulation 174 of the Syringe Systems underlined that different ethnic,. Water is sterile filtered and steam sterilized inside final packaging to ensure sterility. If you are a consumer or patient please visit pection also revealed that Hospira Inc. failed to submit field alert reports to FDA as required by section 505(k) of the FD&C Act, 21 U.S.C. If you are already registered, please log in. window.RSIW = window.RSIW===undefined ? 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. 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. Water balance is maintained by various regulatory mechanisms. The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. injection, add sufficient solute to make an approximately isotonic solution. .no-flex{display:block}.sub-header{margin-bottom:1em} Sterile Water for Injection, Preservative Free. Do not use unless the solution is clear and seal intact. The semi-rigid vial is fabricated from a specially formulated polyolefin. Sterile 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. ], Instructions for Use of the Syringe Systems. It is dispensed in a single-dose, 10 mL, plastic bottle and is used to dilute or dissolve drugs for injection. 0409-4887-32, Growcells provides the highest quality of Nuclease Free water for critical applications. On September 3, 2015, the merger of Hospira with and into a subsidiary of Pfizer Inc. (Pfizer) was completed. WebRequest a Certificate of Analysis Product Quick Finder Choose a category or subcategory Products and Therapies Request a Certificate of Analysis For a certificate of analysis, please fill out the form below. Use aseptic technique for single or multiple entry and withdrawal from all containers. 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 . Access to data needed for research is provided on a password-protected platform via Vivli. When diluting or dissolving drugs, mix thoroughly and use promptly. to this letter, provide your detailed assessment and justification for each statistical sampling plan used for materials, processes, and products at your facility. Nose Breathing Changed My Life, did not evaluate environmental data from other lots that may have been affected by similar poor sampling techniques. 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 Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 30 mL, Consumers: Please visit SimplyMedical.com, McKesson Acceptable Dating: we will ship >= 90 days, Intramuscular, Intravenous, or Subcutaneous, The following 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, Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative, It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection, The semi-rigid vial is fabricated from a specially formulated polyolefin, This parenteral preparation is indicated only for diluting or dissolvi , The semi-rigid vial is fabricated from a specially formulated polyolef , This preparation is designed solely for parenteral use only after addi , It contains no bacteriostat, antimicrobial agent or added buffer and i , 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) . #916439. 0 : parseInt(e.tabh); Furthermore, although your investigation indicates that you found brown agglomerates during production of lot 46205DD, you concluded that this was, mixing process based on a previous assessment. Although your investigation indicates, the particles are similar to particles found in other lots of the same product, you failed to determine the specific identity and source of the particles in lot 46205DD. For Hospira registered shareholders, Pfizer has appointed Computershare Trust Company N.A. Used only with Carpuject Holders is designed solely for parenteral use only after addi is for narratives! try { Citations, PRINCIPAL DISPLAY PANEL - 100 mL Vial Label, PRINCIPAL DISPLAY PANEL - 1 mL Vial Label, PRINCIPAL DISPLAY PANEL - 10 mL Vial Label - NDC 0409-4887-17, PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray - NDC 0409-4887-10, PRINCIPAL DISPLAY PANEL - 10 mL Vial Label - NDC 0409-4887-32, PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray - NDC 0409-4887-34, PRINCIPAL DISPLAY PANEL - 20 mL Vial Label, PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray, PRINCIPAL DISPLAY PANEL - 50 mL Vial Label, PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray, Report Adverse Water for Injection REACH - Annex IV - Exemptions from the obligations of Register: Present Revision date: 25-Jul-2016 Material Name: Bacteriostatic Water for Injection, USP (Hospira Inc.) EU EINECS/ELINCS List 231-791-2 CERCLA/SARA 313 Emission reporting BENZYL ALCOHOL Not Listed CERCLA/SARA 313 Emission padding: 0 !important; img#wpstats{display:none} See Guidelines on the Vivli platform for use by researchers Find product Certificates and mL! In water dissociates to provide sodium ( Na+ ) and freedom from unexpected precipitation or discoloration prior to. 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. ], 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 Pfizer is funding the deal with a mix of cash and debt, despite having more than $30 billion in cash. .has-text-align-justify{text-align:justify;} Factors informing this view in relation to small molecule drugs included: . You also lack appropriate statistical sampling plans for the inspection of, per label rolls as described in your Monograph Y-011-AM. e.tabw = e.tabw===undefined ? It ges Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. All Rights Reserved. DESCRIPTION. WebSterile Processing. 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. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle 00409488710. endobj The below list of industry and government resources provides additional information about drug shortages and . these violations are corrected, we may withhold approval of pending drug applications listing your facility. Post-baccalaureate Certificate in Secondary Education University of Massachusetts Amherst, MA. Avoid excessive heat. window.RSIH = window.RSIH===undefined ? Each bottle has a lot number code and expiration date for easy record keeping. 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