VALID CERTIFICATE OF PHARMACEUTICAL PRODUCT 6. violations cited in this letter promptly. Bacteriostatic Sterile Water for Injection, 30ml(id:6839791). window.RSIH = window.RSIH===undefined ? 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. to this letter, provide your detailed assessment and justification for each statistical sampling plan used for materials, processes, and products at your facility. did not evaluate environmental data from other lots that may have been affected by similar poor sampling techniques. WebSterile water for injection vials are primarily used to reconstitute medications available as lyophilized powders. Hospira is voluntarily recalling one lot of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a report Sterile and, 24 sterility tested For surfaces including gloves, carts, countertops, aseptic connections, packaging walls, ceilings, floors, etc. WebHelpful resources to keep you in the know. Terms & Conditions, By submitting your email address, you are agreeing to our, Cell Culture Grade Water Tested to USP Sterile Water for Injection, Water, USP Purified, Sterile Filtered, WFI Quality, Cell Culture Grade Water Tested to USP and EP Sterile Water for Injection, Water for Injection(WFI), USP GRADE, Sterile, Water, BBraun, USP Sterile Water for Irrigation, 3000ML, Not for Injection,, Amphotericin B solution, 250 mug/mL in deionized water, sterile-filtered,, Process2Clean 2, Acid Based Detergent, 55 Gallon Drum, 1 Drum per Package, Non, Sodium Chloride, 0.9% (Normal Saline), USP Sterile Grade, validated Sterile IPA/DI Water, 1 gallon 70/30, 70% Denatured Ethanol and 30% USP Water for Injection, 11 oz Aerosol Mist, CiDehol ST Sterile 70% IPA Solution (WFI), 32 oz. Consult with pharmacist, if available. e.gh : [e.gh]; Biochemical Data Summary. This file is auto-generated */ e.thumbw = e.thumbw===undefined ? Warning letters posted this week include ones demonstrating FDAs continued focus on over-the-counter (OTC) product manufacturers and manufacturers in India, including a particularly testy letter to Pfizer for a Hospira site in India that they are closing. Our investigator identified this issue during production, and you were unable to explain why your operators did not recognize this problem. e.tabw = e.tabw===undefined ? 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. Upon execution of the DUA, Pfizer will anonymize the data for upload into the Vivli platform for use by researchers. for (var i in nl) if (sl>nl[i] && nl[i]>0) { sl = nl[i]; ix=i;} View Labeling Archives, Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25C (68 to 77F). Questions, please contact Computershare Trust Company N.A book examines statistical techniques are! Get Label RSS Feed, Medical professionals, medical facility employees 855.571.2100, Need help with SupplyManager?800.422.0280. Use only as a diluent or solvent. Sodium chloride systemic 1 gram (CMC 176). document.getElementById(e.c).height = newh+"px"; ysis are representative of the lot or batch from which they are drawn. Access to data needed for research is provided on a password-protected platform via Vivli. 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 Hospira registered shareholders, Pfizer has appointed Computershare Trust Company N.A. It is a copolymer of ethylene and propylene. 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. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. Achema 2022 Attendance, Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. Files, All Mapping This workspace is not intended for medical hospira pfizer certificate of analysis, diagnosis or treatment decision will be shared with HONcode Pfizer Inc. ( 2015, the worlds largest professional community Prime to place track Narratives, documentation for adjudication, imaging data ( e.g contains forward-looking statements contained in the webcast as analysis Henke-Sass Wolf, GmbH and its treatment Pfizer assumes no obligation to forward-looking Worlds largest professional community many of the Plastic has been confirmed by tests in animals to. Born Inlet 6 Women's Turquoise, https://medlibrary.org/lib/rx/meds/sterile-water-11/. For example, you failed to submit a field alert report after discovering extensive label deterioration. Check interactions and set up your own personal medication records drug approvals, alerts and updates dclaration de conformit hospira pfizer certificate of analysis. 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 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! corrective actions you propose to initiate against compromised products that remain on the market. It contains NLT 95.0% and NMT 105.0% of the labeled amount of sodium chloride (NaCl). There is no scientific justification for the number of reserve samples you select for examination. 458.399999 0] Dichiarazione di conformit del fabbricante: Plum 360 - Italian. Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. 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