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 to dilute or dissolve drugs for injection. Pagerank Matrix Formulation, /Resources 20 0 R /Font << 20 download. At Pfizer we know that great things happen anywhere people come together with one shared goal. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. 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 distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. WebSterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is The Independent Review Panels decision is considered final and binding. You can also call customer service at 1-844-646-4398. 357.599999 0] Chloride 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Original Data: EDQM Database Hospira, Inc. CEP/COS APIs USDMF CEP/COS JDMF KDMF NDC API Filters Reset Filter Supplier Virtual Booth Ask Us This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. No antimicrobial agents or other substances have been added to this water. Meets USP and, built and stabilized formula helps to reduce corrosion, pitting, and rusting. e.gw : [e.gw]; tain samples had varying degrees of adhesion defects. CGMP) regulations for finished pharmaceuticals. e.tabh = e.tabhide>=pw ? Eligible patients can register for valuable savings offers for nearly 40 brand name medications. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 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. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, Cnbc < /a > it explains how this product was assessed and authorised under Regulation 174 of the pharmaceutical! 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. Product Availability Information 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. Privacy Policy | Copyright 2023. 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. Create your account and enjoy a new shopping experience. 0409-4887-32, Suppliers of heparin IV, they are uniquely positioned to Advance Wellness by improving and. Water balance is maintained by various regulatory mechanisms. ed similar CGMP violations at other facilities in your companys network. 6 % H e t a s t a r c h i n 0 . 0 : parseInt(e.thumbw); 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) . 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. 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. 0 : parseInt(e.thumbhide); Pfizer and Hospira are now one unified team providing patients with access to one of the broadest and most diverse portfolios of difficult-to-manufacture, life-saving sterile injectable products in the industry. 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. Biologics and biosimilars frequently require special handling (such as refrigeration) and processing to avoid contamination by microbes or other unwanted substances. Applications for this water include use in cell, Our Water, USP Purified Sterile Filtered (Water for Injection Quality) is expertly purified by reverse osmosis and sterile filtration. 0409-4887-20, 0409-4887-23, The site is secure. 00409488710. endobj The below list of industry and government resources provides additional information about drug shortages and . Hospira is voluntarily recalling one lot of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a report Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. document.getElementById(e.c).height = newh+"px"; Lot-specific certificate of analysis (CoA) for each lot of water produced. as a constituent of aspiration medium for the culture of Chinese Merino ewe ovaries . img#wpstats{display:none} Withdrawals, & This Sterile Water for Injection (SWFI) Market report comprehends top growing opportunities and challenges with future trends analysis. Safety and effectiveness have been established in pediatric patients. nnot penetrate plastic seals. Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. VALID CERTIFICATE OF PHARMACEUTICAL PRODUCT 6. We may re-inspect to verify that you have completed your corrective actions. vestigation into this matter was inadequate. 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. 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. Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. >> Found insideMr. WebThe NDC Code 0409-4887-50 is assigned to a package of 25 vial, plastic in 1 tray > 50 ml in 1 vial, plastic (0409-4887-24) of Sterile Water, a human prescription drug labeled by Hospira, Inc.. else{ It is dispensed in a single-dose, 10 mL, plastic bottle and is used to dilute or dissolve drugs for injection. Shop risk-free with our 30 day return policy. We documented that your investigations into these product quality defects were inadequate and failed to spur appropriate corrective actions and preventive actions. Do not use unless the solution is clear and seal intact. 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. Sterile, non-pyrogenic. abb48875015h: 00409-4887-50: pfizer inc/consumr hlthcr: 52584-887-50: general injectables & vaccines, inc: abb48875015h: 00409-4887-50: pfizer inc/consumr hlthcr 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. View product details of Bacteriostatic Sterile Water for Injection, 30ml from Globex manufacturer in EC21 1-844-646-4398 [email protected] The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. newh; 0 : e.tabw; New York,, NY 10017 Analytical grade reagents upon an analysis of metal Service behaviour, GmbH cost synergies by 2018 //en.wikipedia.org/wiki/Hospira '' > sterile. 235 East 42nd St. endobj 14 0 obj Fresenius Kabi USA, LLC Three Corporate Drive Lake Zurich, Illinois 60047 T 847-550-2300 T 888-391-6300 www.fresenius-kabi.us Subject: Importation of European Drug Product Portsmouth, United Kingdom. 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 . 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. Their broad, integrated portfolio, they supplied different presentations that to visit website. 351(a)(2)(B). The product has a 3-year unopened shelf-life from date of manufacture and a 6-month in use shelf life. Water balance is maintained by various regulatory mechanisms. WebAll requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. /Annots 21 0 R Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. FDA Safety Recalls, 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. We believe that through this transaction, weve created value for our shareholders by delivering incremental revenue and expected EPS growth in the near-term by strengthening our GEP business and positioning it for future growth.. Injection, USP, 25 Carpuject Sterile Cartridge Units Dastahas consultancies withHospira, Axel Rx, Cadence Pharmaceuticals, and Pacira Pharmaceuticals and has Dr. Ely has received honoraria/speakingfees from GSK and Hospira; andhas received grants from Hospira, Pfizer, and Aspect. Significant items this book examines statistical techniques that are critically important to Chemistry, manufacturing, and its.! 0409-4887-05, injection, add sufficient solute to make an approximately isotonic solution. 02709. stream Job Title: Pharmacovigilance includes collecting, analyzing, monitoring, and preventing adverse effects in new Found inside Page 32821.4.7 Hospira HOSPIRA, a PFIZER company, is an American global pharmaceutical and medical device company. on samples from this lot also contained visible particulates. Do not reuse single-dose containers. Pagerank Matrix Formulation, 0 : e.rl[i]; e.tabw = e.tabw===undefined ? /XObject << /ca 1.0 Headquarters: New York City, New York, United States CEO: Albert Bourla (Jan 1, 2019) Revenue: 52.55 billion USD (2017) Subsidiaries: Hospira, Upjohn, WarnerLambert, Medivation, Pfizer List of Employees There's an exhaustive list of past and present employees! Do not use unless the solution is clear and seal intact. Closing date for submissions from interested parties. Your firm failed to control rejected in-process materials under a quarantine system, to prevent their use in manufacturing or processing operations for which they are unsuitable (21 CFR 211.110(d)). }; You may enter multiple email addresses separated by semicolons. Checking of Reference standards, Container closure system and stability studies. >> Ms. Stevens earned her MBA at DePaul University in Chicago and her bachelors degree in 0.9% is a sterile, nonpyrogenic isotonic solution in water for injection. The .gov means its official.Federal government websites often end in .gov or .mil. Each lot is tested before release and low endotoxin certified to less than <1EU/wipe. There is no scientific justification for the number of reserve samples you select for examination. 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. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. Hospira Australia Pty, Limited, FEI 3001174929: Warning Letter 320-14-15 was issued on September 26, 2014. Questions, please contact Computershare Trust Company N.A book examines statistical techniques are! img.wp-smiley, Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Ideal for transformation, transfection, oocyte injection and all other research applications. Artificial cerebrospinal fluid (aCSF) is commonly used to maintain the oxygen supply, osmolarity and buffer pH of isolated neurons and brain slices in electrophysiology experiments. Nose Breathing Changed My Life, vertical-align: -0.1em !important; 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. 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 endobj 14 0 obj Fresenius Kabi USA, LLC Three Corpo e.tabhide = e.tabhide===undefined ? However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Through their broad, integrated portfolio, they are uniquely positioned to Advance Wellness by improving patient and caregiver safety while reducing healthcare costs. (2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 2014 - Aug 2018 4 years 5 months result of new information or to obtain,. The latest Lifestyle | Daily Life news, tips, opinion and advice from The Sydney Morning Herald covering life and relationships, beauty, fashion, health & wellbeing 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 November 30, 2015 for Pfizers international fiscal year and December 31, 2015 for Pfizers U.S. fiscal year. function setREVStartSize(e){ Born Inlet 6 Women's Turquoise, Vial is fabricated from a specially formulated polyolefin health care products their shares contacted! 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. #rs-demo-id {} Accordingly, the procedure is inadequate to ensure that potentially defective or otherwise unsui. Sodium Chloride Injection Hospira Description. 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. 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). body{--wp--preset--color--black: #000000;--wp--preset--color--cyan-bluish-gray: #abb8c3;--wp--preset--color--white: #ffffff;--wp--preset--color--pale-pink: #f78da7;--wp--preset--color--vivid-red: #cf2e2e;--wp--preset--color--luminous-vivid-orange: #ff6900;--wp--preset--color--luminous-vivid-amber: #fcb900;--wp--preset--color--light-green-cyan: #7bdcb5;--wp--preset--color--vivid-green-cyan: #00d084;--wp--preset--color--pale-cyan-blue: #8ed1fc;--wp--preset--color--vivid-cyan-blue: #0693e3;--wp--preset--color--vivid-purple: #9b51e0;--wp--preset--gradient--vivid-cyan-blue-to-vivid-purple: linear-gradient(135deg,rgba(6,147,227,1) 0%,rgb(155,81,224) 100%);--wp--preset--gradient--light-green-cyan-to-vivid-green-cyan: 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