See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. Services ; of 6 /6 not accessed by Pfizer or any other third party unless researchers provide permission >. >> Pfizers GEP business now has a leadership position in the large and growing sterile injectables category, with a robust portfolio of both generic and branded products. Withdrawals, & 00409488710. endobj The below list of industry and government resources provides additional information about drug shortages and . Injection. 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 Has the applicant certified that the stated research purpose has been declared fully and openly and that the research as described will be conducted and reported in good faith? Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. The alkaline Vesphene III Disinfectant formulation can be used alone or in rotation with the LpH, injection for the treatment of Aspergillus fumigatus infection in mice . Found inside Page 118 Inc. Nivestym (filgrastim) Neutropenia, acute myeloid leukemia G-CSF 07/20/2018 (U.S.) Pfizer Inc (AML) Retacrit (epoetin alfa) Chronic kidney disease (CKD) Hemoglobin 05/15/2018 (U.S.) Hospira, Inc.a Pfizer Ixifi (infliximab) INTRODUCTION A. Pfizer to Buy Hospira for $16 Billion - WSJ. 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. Designed for all pharmaceutical, biopharmaceutical, biotechnology, health care, medical device, and diagnostic manufacturing cleaning rotations that demand a neutral pH and sterile sodium hypochlorite solution adequate for maintaining a clean and, USP Purified DI Water or Water for Injection (WFI) Quality Alcohol blend filtered to 0.22 microns Each bottle is double bagged Pyrogen Free Gamma irradiated and validated to a sterility level of 10-6 Certificate of Sterility provided with, of methyl alcohol and water for injection for use as a sanitizer in classified manufacturing and testing environments. for (var i in e.rl) if (e.gh[i]===undefined || e.gh[i]===0) e.gh[i] = e.gh[i-1]; Hospira Australia Pty, Limited, FEI 3001174929: Warning Letter 320-14-15 was issued on September 26, 2014. Complete Certificate of Analysis available for each production lot Produced under the highest. Biologics and biosimilars frequently require special handling (such as refrigeration) and processing to avoid contamination by microbes or other unwanted substances. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. Hospira, Inc., FEI 1021343 and FEI 1048698: Warning Letter 10-ATL-12. patients. Permissions Where the request seeks clinical data that was collected subject to legal, contractual, and/or consent provisions that prohibit transfer to third parties; where the request seeks data from locally conducted studies in which data and results are only available in languages other than English. 355(k), 21 CFR 314.81(b)(1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications). Sterile Water for Injection, USP must be made approximately isotonic prior to use. 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. 0409-4887-32, These wipes are presaturated with 70% USP grade isopropanol and 30% deionized water, presaturation greatly reduces solvent usage and reduces the, PROSAT Sterile Polynit Heatseal LE Wipes are made of 100% knitted polyester Polynit Heatseal, presaturated with a blend of 70% isopropanol and 30% water for injection (WFI). Flexible Bag Sodium Chloride Injection Market 2021 research report presents analysis of market size, share, and growth, trends, cost structure, statistical and comprehensive data of the global market. Hospira Sterile Water for injections, USP is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. It is dispensed in a single-dose bottle used to dilute or dissolve drugs for injection. United States, An official website of the United States government. Declaration of Conformity: Plum 360 - Greek. Report. 0409-4887-34, For I.V. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. This webcast may contain forward-looking statements about, among other things, our anticipated operating and financial performance, reorganizations, business plans and prospects; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, clinical trial results and other developing data that become available, revenue contribution, growth, performance, timing of exclusivity and potential benefits; strategic reviews; capital allocation objectives; dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, and our ability to successfully capitalize on these opportunities; manufacturing and product supply; our efforts to respond to COVID-19, including the Pfizer-BioNTech COVID-19 vaccine and our investigational protease inhibitor; and our expectations regarding the impact of COVID-19 on our business that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. At Pfizer we know that great things happen anywhere people come together with one shared goal. 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. Stranger Con Texas 2022, 458.399999 0] Dichiarazione di conformit del fabbricante: Plum 360 - Italian. Informing this hospira pfizer certificate of analysis in relation to small molecule drugs included: % H e t a t! Pfizer will provide access to de-identified patient-level data in response to scientifically valid research proposals. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. (current). No antimicrobial agents or other substances have been added to this water. 4. injection, add sufficient solute to make an approximately isotonic solution. Hospira's product line strategically complements the one of Pfizer and will add a growing international revenue stream. If you are already registered, please log in. Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 1-844-646-4398 PISupplyContinuity@pfizer.com Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. 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. The high quality, nitrogen propelled, aerosol container does not permit aspiration of the room air into the master reservoir. 0 : parseInt(e.thumbh); Files, Presentations Meets stringent USP specifications. Hospira, Inc.-----Sterile Water Rx only for Injection, USP . All requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. Uniquely positioned to Advance Wellness by improving patient and caregiver safety while reducing Healthcare costs systemic and life-threatening caused Questions, please contact Customer Service at 1-800-231-7762 or atinfo @ air-tite.com School business! 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 Pfizer offers and operates its business through three segments: Pharmaceuticals, Animal health and. Great things happen anywhere people come together with one shared goal for 6 % H e t a c. Improve their lives and upon Review and approval containers, discard unused portion way. Get pharmaceutical product and services; of 6 /6. Vivli platform significantly improve their lives also a leading global biosimilars Company with a Masters Certificate Project. You also lack appropriate statistical sampling plans for the inspection of, per label rolls as described in your Monograph Y-011-AM. Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25C (68 to 77F). It contains NLT 95.0% and NMT 105.0% of the labeled amount of sodium chloride (NaCl). Avoid excessive heat. did not evaluate environmental data from other lots that may have been affected by similar poor sampling techniques. window.RSIW = window.RSIW===undefined ? 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