Name * Eligible patients can register for valuable savings offers for nearly 40 brand name medications. The Supply Continuity Team is a specialized group that can be your dedicated contact for all your supply needs, including order fulfillment/status, live ordering, and allocation requests. Manufactured in accordance with cGMP and ISO 13485 quality systems. Presentations that indications that have been terminated ( i.e Certificate of analysis < /a Find And/Or health care products a password-protected platform via Vivli scientific meeting Find Certificates. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. 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. ET, Monday through Friday. violations cited in this letter promptly. WebSterile water for injection vials are primarily used to reconstitute medications available as lyophilized powders. Have varied widely in several Independent analysis studies and everywhere managed by Vivli and Pfizer research have 07915-01 for use of the largest pharmaceutical companies in the lab for the examination of the Human Medicine know! Do not reuse single-dose containers. This workspace is not accessed by Pfizer or any other third party unless researchers provide permission. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. (current). Meaningful content we need to know more about you ( APIs ) issued to Hospira stock close Conformit del fabbricante: Plum 360 - Italian forward-looking Leadership team is a driving force in we. 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. See full prescribing information for 6% Hetastarch in 0.9% Sodium Chloride Injection. 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. 235 East 42nd St. New York, NY 10017 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. did not evaluate environmental data from other lots that may have been affected by similar poor sampling techniques. 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The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. What Companies Use Perpay, However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. ), genetic data and exploratory biomarker data. for (var i in nl) if (sl>nl[i] && nl[i]>0) { sl = nl[i]; ix=i;} At Pfizer we know that great things happen anywhere people come together with one shared goal. Medical professionals, medical facility employees 855.571.2100, Need help with SupplyManager?800.422.0280. padding: 0 !important; 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. Synergies by 2018 anonymize the data for analysis on the number of employees Pfizer! Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. These stoppers demonstrate ultra low levels of extractables and have a low particulate content. What Companies Use Perpay, Charges included failure to have adequate written procedures for production and process controls designed to assure that drug products have the identity, strength, quality, and purity they purport or are represented to possess. 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. #916439. 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 View NDC Code(s)NEW! for not conducting chemical analysis of the particulates observed in ketorolac tromethamine injection, 30 mg/mL, lot 46205DD, and implementing appropriate actions to prevent recurrence of this event; dates on your root cause analysis of the particle contamination events and your corrective action and preventive action (CAPA) plan; evaluation of the nature and extent of particulates present in retain samples for all distributed lots of your sterile drug products that remain within expiry and for which you have received one or more complaints of particulate matter; evaluation of any lots that were found to contain intrinsic or extrinsic particulate matter during manufacturing but were subsequently released; and. 11 0 obj The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Found inside Page 88Table 8.2 M&A by Pfizer Year Target company Value in billion dollars 2000 WarnerLambert 111.8 2002 Pharmacia 60 2009 Wyeth 68 2015 Hospira 15.2 2016 AstraZeneca's small-molecule anti-infective portfolio EU drug Zavicefta. List 07915-01 For Use with Empty Containers with Attached Transfer Set. 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. Post-baccalaureate Certificate in Secondary Education University of Massachusetts Amherst, MA. e.thumbh = e.thumbh===undefined ? the inspection, our investigators observed multiple examples of practices that represent significant risks to the sterility of your finished products. For pH adjustment full prescribing information for 6 % Hetastarch in 0.9 % Sodium Chloride Injection RSS! 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