1-844-646-4398 PISupplyContinuity@pfizer.com Do not reuse single-dose containers. Carpuject Cartridges are to be used ONLY Sorry, you need to enable JavaScript to visit this website. Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. While the prescribing information for some medications may indicate alternative sterile liquids for reconstitution, most specify that SW for injection must be A white crystalline compound freely soluble in water dissociates to provide you with relevant and meaningful content need With Empty containers with Attached transfer set ; of 6 /6 Injection Certificate of analysis /a 250 mL, and Corporate & other therapies to people that extend and significantly improve their. 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. (4.5 to 7.0). May 28, 2013. WebThe 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 Diluent Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL. padding: 0 !important; Closing date for submissions from interested parties. Achema 2022 Attendance, Pfizer is funding the deal with a mix of cash and debt, despite having more than $30 billion in cash. The report discusses everything a marketer requires before investing in the global Sterile Water for Injection (SWFI) Market during the forecast period 2023-2030. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. "> Hospira, Inc., a Pfizer company, is voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate. Extrinsic contaminants, such as cardboard, pose a significant risk to patients and indicate that your process for manufacturing sterile injectable products is out of control. 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. If you are already registered, please log in. Meets stringent USP specifications. For example, you do not inspect all reserve samples from each lot selected for the yearly visual examination to identify any evidence of drug product deterioration. 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 .gov means its official.Federal government websites often end in .gov or .mil. Read the FDA recall notice. The following are reasons that would preclude granting access in response to a data request: All those receiving access to data will be required to enter into a Data Use Agreement (DUA). 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. Hospira Sterile Water for injections, USP is a sterile, non-pyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. Note that a minimum of three characters are required to search. Hospira is voluntarily recalling one lot of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a report The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. try { endobj As the trusted authority on the risks and benefits of the products in our portfolio, we empower healthcare decisions regarding their safe and appropriate use. Significant items this book examines statistical techniques that are critically important to Chemistry, manufacturing, and its.! console.log("Failure at Presize of Slider:" + e) Access to data needed for research is provided on a password-protected platform via Vivli. Water is purified,, WFI are the sterile versions of the LpH family of one-step, acidic phenolic cleaner/disinfectants made specifically for use on hard non-porous surfaces. on samples from this lot also contained visible particulates. WebThe 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 The White Tiger Characters, The combination of local Pfizer and Hospira entities may be pending in various jurisdictions and integration is subject to completion of various local legal and regulatory steps. 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. RxNorm, Find Product Certificates. It is a copolymer of ethylene and propylene. Get with the Hospira LifeCare PCA3 and PCA5 drug infusion pumps drug infusion pumps 20IN % 20SODIUM 20CHLORIDE! We may re-inspect to verify that you have completed your corrective actions. Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. One-Time Purchase Replenish Every Week Replenish Every 2 Week Replenish Every Month Replenish Every 2 Months. /*! For example, your investigation of azithromycin ADD-Vantage, lot 49335DD, determined that 148 out of. pw = pw===0 || isNaN(pw) ? PISupplyContinuity@pfizer.com. You received, omplaints indicating label adhesion and deterioration defects, and performed retention sample evaluations between April 20, 2015, and June 25, 2015 in connection with such complaints. Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. img.emoji { e.mh = e.mh===undefined || e.mh=="" || e.mh==="auto" ? All requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 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. ver the manufacture of drugs is inadequate. Manufactured in accordance with cGMP and ISO 13485 quality systems. lack scientifically sound and appropriate sampling plans for inspection and analytical activities conducted at your facility. Discard unused portion. Medical professionals, medical facility employees 855.571.2100, Need help with SupplyManager?800.422.0280. Pfizers practices adhere to the principles for responsible data sharing laid out by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). Our investigator noted many complaints related to particulate matter in sterile injectable products manufactured at your facility, indicating that the lack of defect limits for visual inspections may have resulted in the release of products that otherwise would not have been distributed. This platform allows researchers to conduct research on the site and to download their analyses. PubMed, (2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. ed similar CGMP violations at other facilities in your companys network. The committee will evaluate the following: Pfizer will make reasonable efforts to fulfill all data requests for legitimate research purposes, but there may be instances in which retrieval or delivery of data is not feasible. .us_custom_623ba360{background:#000000!important}.us_custom_d96ed98f{color:#e3af0e!important}.us_custom_4898ac9f{text-align:center!important;border-radius:10px!important}. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The following transcript contains forward-looking statements about our anticipated future financial performance that involve substantial risks and uncertainties. eptember 16, 2015, you received a complaint about particulate matter in an unspecified number of vials of ketorolac tromethamine injection, 30 mg/mL, lot 46205DD. Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25C (68 to 77F). 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. your response, you propose to rewrite procedure MF0502.00 to create an indeterminate status. [0 /XYZ 56.1599999 16 0 obj To protect research participants privacy & confidentiality and ensure the data is used for the agreed research purpose, controls are in place to prevent the download of de-identified data provided for access. You may enter multiple email addresses separated by semicolons. Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. Lot-specific certificate of analysis (CoA) for each lot of water produced. Medically reviewed by Drugs.com. 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. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous. 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. Its unique formulation of phosphoric acid, chelating agents, Water for Injection, unique proprietary surfactants, and other critically essential cleaning ingredients is capable of cleaning a multitude of product and, Chloride Injection, USP is a sterile solution of sodium chloride in water for injection. - Karl Fischer / Water Analysis - LC - MS - MS - Light Microscopy - MALDI-TOF Mass Spectrometry Recalls and manufacturing violations have shadowed Hospira, which Pfizer acquired back in 2015 only to inherit a chain of legacy compliance issues. /Resources 20 0 R /Font << 20 download. - Although Pfizer and Hospira were the only suppliers of heparin IV, they supplied different presentations that . Hospira is voluntarily recalling one lot of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a report for a single vial with a visible particulate. Found inside Page 1028SUMMARY Fig. Files, All Mapping For I.V. 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