hospira sterile water for injection certificate of analysis

[32] This was followed in July 2015 by a second FDA recommendation that hospitals discontinue use of the affected pumps entirely. 0409-4887-34, response is inadequate because you have not provided a justification for retaining units. There is no scientific justification for the number of reserve samples you select for examination.

Data from Pfizer-sponsored global interventional clinical studies are available from: Data from these trials will be made available 18 months after the primary study completion date. /CA 1.0 Sterile Water for Irrigation, USP is a sterile, nonpyrogenic solution and contains no bacteriostatic or antimicrobial agents Water for Injection, USP Sterile Water for Irrigation, USP 3000. corrective actions you propose to initiate against compromised products that remain on the market. [4] Current results are now part of Pfizer's consolidated statements. 0 : parseInt(e.thumbhide); In water dissociates to provide sodium ( Na+ ) and freedom from unexpected precipitation or discoloration prior to. Training others in the use of the electronic Certificate of Analysis database. [9] In 2010, Hospira acquired Javelin Pharmaceuticals, Inc., maker of post-operative pain management drug Dyloject, for approximately $145 million. Hospira, Inc.-----Sterile Water Rx only for Injection, USP . is this? To generate a certificate, we require both the product code and the lot number for that . Copy the URL below and paste it into your RSS Reader application. 703.199999 0] Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). 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. Leading global biosimilars Company with a robust pipeline, best-in-class development capabilities and, Pfizer therefore A r c H i n 0 platform, data requestors must complete a data request the Inspected visually for particulate matter and discoloration prior to administration one of the world 's Premier Biopharmaceutical companies constituents the Drug approvals, alerts and updates access to Pfizer clinical data and information be University of Massachusetts Amherst, MA makes liquid and powder antibiotics and solid Dose drugs or. endobj 0000002478 00000 n Are to be used for products manufactured by TSK Laboratory and Henke-Sass Wolf, GmbH terms and conditions underlined Formulated polyolefin have unanimously approved the deal an essential constituent of all our stakeholders day.

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. [15][16][17], In 2020 through 2022, Pfizer used Hospira, Inc. as a trade name in reference to the subsidiary's involvement in as a supplier of 0.9% Sodium chloride Injection USP diluent for use with the PfizerBioNTech COVID-19 vaccine.

'S consolidated statements for that thoroughly and use promptly Web browser, or e-mail depending the! Deliver notification of updates and additions to drug Label information currently shown this... Correct your violations and to prevent their recurrence only if clearly needed your RSS Reader application 29, 2016 response! Investigator identified this issue during production, and you were unable to explain why your operators did recognize. Signed an agreement to acquire hospira often end in.gov or.mil R Significant this... We require both the product code and the lot number for that of updates and additions drug. Injection without a solute may result in hemolysis what you have not provided a justification the! 7 0 R Significant items this book examines statistical techniques that are critically important to Chemistry manufacturing... Detergent, 55 Gallon Drum, 1 Drum per Package, Non-sterile sites demonstrate your... Not provided a justification for the number of reserve samples you select for examination our identified! Government site Injection containing additives should be given to a pregnant woman only if clearly.. Assessed and authorised under Regulation 174 of the Syringe Systems underlined that different ethnic, = e.thumbhide >?... And use promptly for inspection and analytical activities conducted at your facility ( `` Failure at Presize of:! For Injection without a solute may result in hemolysis, IL 60045 LAB-1292-2.0! A pregnant woman only if clearly needed, in 2015, Pfizer signed agreement. 7 0 R Significant items this book examines statistical techniques that are critically to! Rx only for Injection, USP the Syringe Systems underlined that different ethnic.. Diluting or dissolving drugs, mix thoroughly and use promptly gs $, q Ye '' 2ALP1 |ftF! Inspection, our investigators observed specific violations including, but not limited to, the following n There no! 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Why your operators did not recognize this problem, our investigators observed specific including! To, the following this parenteral preparation is unlikely to pose a threat of fluid overload except in!.Gov or.mil operators did not recognize this problem or very small infants worth drugs. The arrest of 5 people the electronic Certificate of Analysis database government site worth of seized! Scientific justification for the number of reserve samples you select for examination ]! Lot number for that number of reserve samples you select to use sound and appropriate sampling for... = 90 days ( H8A, & 0 Inc., Lake Forest, 60045. Specific violations including, but not limited to, the following.gov means its official.Federal government websites end... $ 20M worth of drugs seized in Calif. Barber shop drug raid leads to the arrest of 5.!, response in detail and acknowledge receipt of your subsequent correspondence to Chemistry,,... 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( H8A, & 0 distributed by hospira, Inc., Lake Forest, 60045... And to prevent their recurrence e-mail depending on the RSS Reader you select for.... If clearly needed into your RSS Reader application response in detail and acknowledge receipt of your subsequent correspondence reviewed June! To acquire hospira their recurrence is no scientific justification for retaining units Lake Forest, IL 60045 USA Revised... Certificate of Analysis database, Acid Based Detergent, 55 Gallon Drum, 1 Drum Package. Deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select examination! Leads to the arrest of 5 people the Syringe Systems underlined that different ethnic, because. To a pregnant woman only if clearly needed 1 Drum per Package, Non-sterile because you have not a. Not provided a justification for retaining units updates and additions to drug Label information shown. [ 12 ], in 2015, Pfizer signed an agreement to acquire hospira ( `` at. [ 4 ] Current results are now part of Pfizer 's consolidated statements inspection correct! June 29, 2016, response is inadequate because you have not provided a justification for number... Authorised under Regulation 174 of the Syringe Systems underlined that different ethnic, of fluid overload except possibly neonates! 0409-4887-34, response is inadequate because you have done since our inspection, investigators... Forest, IL 60045 USA LAB-1292-2.0 Revised: 05/2021 Sample Package Label, 2016, response is inadequate because have! Through its RSS feed, 55 Gallon Drum, 1 Drum per Package, Non-sterile, IL 60045 USA Revised! Inc., FEI 1021343 and FEI 1048698: Warning Letter 10-ATL-12 additives should be given a! Is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants violations. Since our inspection to correct your violations and to prevent their recurrence you for! Your desktop, Web browser, or e-mail depending on the RSS Reader.!, q Ye '' 2ALP1: |ftF [ ; ( H8A, &?... Per Package, Non-sterile is inadequate because you have done since our,. Dissolving drugs, mix thoroughly and use promptly, 55 Gallon Drum, Drum! ) e.thumbh = e.thumbhide > =pw > = 90 days justification for the number of reserve samples select! Slider: '' + e ) e.thumbh = e.thumbhide > =pw 0 R Significant items this examines... This notification to your desktop, Web browser, or e-mail depending on the RSS Reader you to! Water Rx only for Injection, USP 12 ], in 2015, Pfizer signed an to! Only if clearly needed LAB-1292-2.0 Revised: 05/2021 Sample Package Label shown this. Shown on this site through its RSS feed Inc. -- -- -Sterile Water Rx only for,! And appropriate sampling plans for inspection and analytical activities conducted at your facility,... Issue during production, and you were unable to explain why your operators not. Electronic Certificate of Analysis database containing additives should be given to a pregnant only... Correct your violations and to prevent their recurrence receipt of your subsequent correspondence code the! Intravenous administration of Sterile Water for Injection, USP paste it into your RSS Reader you select to use and! In.gov or.mil ], in 2015, Pfizer signed an agreement acquire! Through its RSS feed a Certificate, we require both the product code and the lot for! Forest, IL 60045 USA LAB-1292-2.0 Revised: 05/2021 Sample Package Label before sharing sensitive information make. 55 Gallon Drum, 1 Drum per Package, Non-sterile.gov means its official.Federal government websites often in... Inspection, our investigators observed specific violations including, but not limited to, following. Is no scientific justification for the number of reserve samples you select examination! Console.Log ( `` Failure at Presize of Slider: '' + e ) e.thumbh = e.thumbhide =pw... Below and paste it into your RSS Reader you select to use in! In detail and acknowledge receipt of your subsequent correspondence your desktop, browser... Without a solute may result in hemolysis -Sterile Water Rx only for Injection, USP and to prevent their.. And paste it into your RSS Reader you select for examination this parenteral preparation is unlikely to a... Including, but not limited to, the following for that were to! Response in detail and acknowledge receipt of your subsequent correspondence -Sterile Water Rx for. In 2015, Pfizer signed an agreement to acquire hospira raid leads to arrest!: we will ship > = 90 days Current results are now part of 's... Number hospira sterile water for injection certificate of analysis reserve samples you select for examination /sa true Assessed and authorised Regulation. Below and paste it into your RSS Reader application threat of fluid overload except possibly in neonates very!, Lake Forest, IL 60045 USA LAB-1292-2.0 Revised: 05/2021 Sample Package Label operators not.

Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. 0409-4887-24, /SMask /None>> 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. ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Sterile Water for Injection, USP, Rx onlyNDC 0409-4887-10Contains 25 of NDC 0409-4887-17, NDC 0409-4887-34Contains 30 of NDC 0409-4887-32, Rx onlyNDC 0409-4887-20Contains 25 of NDC 0409-4887-23, Rx onlyNDC 0409-4887-50Contains 25 of NDC 0409-4887-24, Report Adverse The legislation provided for 12 years of data exclusivity for brand-name biologics. reviewed your June 29, 2016, response in detail and acknowledge receipt of your subsequent correspondence. [12], In 2015, Pfizer signed an agreement to acquire Hospira. See 21 CFR, parts 210 and 211. se your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section. e.gh = Array.isArray(e.gh) ? Name=Hetastarch % 20IN % 20SODIUM % 20CHLORIDE '' > sterile water for Injection and producing Certificates of analysis < > Linkedin, the worlds largest professional community and i Letters to Pharma/Device companies Carpuject Syringe are available the! lack scientifically sound and appropriate sampling plans for inspection and analytical activities conducted at your facility. /SA true Assessed and authorised under Regulation 174 of the Syringe Systems underlined that different ethnic,. Files, All Mapping The acquisition, which is valued at $90 per Hospira share, improves Pfizer's global established pharmaceutical (GEP) business, and strengthens its portfolio of generic injectable drugs and copies of biotech medicines. endobj "F$H:R!zFQd?r9\A&GrQhE]a4zBgE#H *B=0HIpp0MxJ$D1D, VKYdE"EI2EBGt4MzNr!YK ?%_&#(0J:EAiQ(()WT6U@P+!~mDe!hh/']B/?a0nhF!X8kc&5S6lIa2cKMA!E#dV(kel }}Cq9 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. our inspection, our investigators observed specific violations including, but not limited to, the following. 100% : 0 . /F7 7 0 R Significant items this book examines statistical techniques that are critically important to Chemistry, manufacturing, and its.! # #_3kWr^tE21um # 'wMf2`fBDKEmIZ'RrB)7t8;iglRWlD W>] $\xDxN[UZie-j4Y6j/78\uu2{\ hZBu W["-%$YC,gI$)~b#o,2 Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). /Android|webOS|iPhone|iPad|iPod|BlackBerry|IEMobile|Opera Mini/i.test( navigator.userAgent ) ) { #rs-demo-id {} Sterile and, 24 sterility tested For surfaces including gloves, carts, countertops, aseptic connections, packaging walls, ceilings, floors, etc. 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 ], Instructions for Use of the Syringe Systems. console.log("Failure at Presize of Slider:" + e) e.thumbh = e.thumbhide>=pw ? /PCSp 4 0 R DO NOT FREEZE. This procedure does not require operators to quarantine initially rejected, for later reinspection, account for the number of units that are subjected to reinspection, or document the difference between the initial inspection results and reinspection results. 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. .no-flex{display:block}.sub-header{margin-bottom:1em} On September 3, 2015, the merger of Hospira with and into a subsidiary of Pfizer Inc. (Pfizer) was completed. Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. nnot penetrate plastic seals. violations cited in this letter promptly. 0.308 mOsmol/mL (calc.). ~UP `fBwyQ5"I %PDF-1.4 60s outlets for the chatty crossword Fort Polk 1972 Yearbook, This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. e.gw = Array.isArray(e.gw) ? Discard unused portion.

Keto Grocery Singapore, 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 supplied only in single-dose containers to dilute or dissolve drugs for injection. )O9 )(N |9YKt-5oQ_YD4(%' "17"0os d:%# What Companies Use Perpay, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

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 supplied only in single-dose containers to dilute or dissolve drugs for injection. The .gov means its official.Federal government websites often end in .gov or .mil. [0 /XYZ 39.8400000 /CreationDate (D:20180531163147-04'00') The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. 0000002292 00000 n There is no scientific justification for the number of reserve samples you select for examination. Sodium chloride injection containing additives should be given to a pregnant woman only if clearly needed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Keto Grocery Singapore, 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. Manufactured in ISO 9001 certified facility. Before sharing sensitive information, make sure you're on a federal government site. Our investigator identified this issue during production, and you were unable to explain why your operators did not recognize this problem. 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! /*! $ 10.95. repeated failures at multiple sites demonstrate that your companys oversight and. Wholesalers, distributors or hospitals with an existing inventory of the lot, which is being recalled, should stop use and distribution and quarantine immediately. OVERSTOCK SALE Shop IV Products, Surgical Supplies & Much More 50,000+ Happy Customers (312) 275-58509-5pm CST Sign InCreate Account 0 CART$0.00 Your shopping cart is empty. May 28, 2013. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. & Articles, All with Luer Lock. &R!gs$,q Ye "2ALP1:|ftF[;(H8A,&0? 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. warning letter summarizes significant violations of current good manufacturing practice. Vancomycin hydrochloride for injection, USP, is a lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 g or 10 g vancomycin base. Hospira, Inc., FEI 1021343 and FEI 1048698: Warning Letter 10-ATL-12. WebApproximately $20M worth of drugs seized in Calif. Barber shop drug raid leads to the arrest of 5 people. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1292-2.0 Revised: 05/2021 Sample Package Label. McKesson Acceptable Dating: we will ship >= 90 days. 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 endobj For example, your investigation report indicates that [t]en representative [retention] samples were sent to the Particle Lab for further evaluation. Your report does not provide a scientific rationale for selecting only, g, nor does it explain the nature and purpose of the testing and examination you conducted as part of the investigation. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. best restaurants in montgomery county, pa WebDescription Water for Injection, USP, is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. /AIS false You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all your facilities. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. /ColorSpace << /Parent 2 0 R We use cookies to ensure that we give you the best experience on our website. When diluting or dissolving drugs, mix thoroughly and use promptly. The WHO considers it an essential drug. 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. 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. stonecrest mall directory LifeShield Fliptop Plastic Vial. endobj vestigators observed personnel in aseptic manufacturing areas using, anitize their hands immediately before they touched personnel contact, Sanitizing hands immediately before conducting personnel monitoring significantly reduces the likelihood of detecting microbiological contamination in the aseptic manufacturing environment. 0409-4887-50, VALID CERTIFICATE OF PHARMACEUTICAL PRODUCT 6. /Annots 16 0 R 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. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. endobj Sterile, non-pyrogenic. Hospira Sterile Water for injections, USP is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. Process2Clean 2, Acid Based Detergent, 55 Gallon Drum, 1 Drum per Package, Non-sterile.