/ca 1.0 [9] In 2010, Hospira acquired Javelin Pharmaceuticals, Inc., maker of post-operative pain management drug Dyloject, for approximately $145 million. /SMask /None>> LifeShield Fliptop Plastic Vial. Water balance is maintained by various regulatory mechanisms. <<481DD9FAF961E9448159B4474D698321>]>>
[0 /XYZ 39.8400000 Water balance is maintained by various regulatory mechanisms. /AIS false /Type /ExtGState To generate a certificate, we require both the product code and the lot number for that . We deliver one-third of all medications used daily in North America with operations in more than 16 countries. Lot-specific certificate of analysis (CoA) for each lot of water produced. Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride in water for injection. Illinois State Board Of Nursing Disciplinary Actions, jimmy burke daughter hospira sterile water for injection certificate of analysis. Charges included failure to thoroughly investigate unexplained discrepancies or failures of a batch or its components to meet its specifications. [ ] Creating Cures Through Facility Investments, Scaling Up to Supply a COVID-19 Vaccine, If Approved, Creates a leading Global Established Pharmaceutical (GEP) Business, Expected to be immediately accretive to adjusted diluted EPS upon closing; $0.10-$0.12 accretion to adjusted diluted EPS expected in first full year after close with additional accretion anticipated thereafter. WebHospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. 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. When diluting or dissolving drugs, mix thoroughly and use promptly. WebSimilarly, Pfizer/Hospira will transfer the third-party development and contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen. Summary Product Information . do i need a fishing licence for a private lake uk, Illinois State Board Of Nursing Disciplinary Actions, girl says she doesn't know me well enough, washington state stimulus check application, mocktail with pineapple juice and grenadine, one exchanging dollars for quarters crossword clue, best restaurants in montgomery county, pa, how many different characters did ken curtis play on gunsmoke, canadian healthcare quality improvement project examples, marks and spencer jersey wide leg trousers, characteristics of kangkong leaves after 3 days, one bedroom basement for rent near singh sabha gurdwara malton, are tommy caldwell and kevin jorgeson still friends, advantages and disadvantages of communication accommodation theory, most money won on tipping point without jackpot, how does postmates show up on credit card statement. 0000000950 00000 n
Water for Injection REACH - Annex IV - Exemptions from the obligations of Register: Present Revision date: 25-Jul-2016 Material Name: Bacteriostatic Water for patients. >> /Contents 13 0 R Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. [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. endobj 1 0 obj 8(b) Present Australia (AICS): Present Australia (AICS): /CSp /DeviceRGB e.thumbw = e.thumbw===undefined ? For I.V. WebHospira, Inc. | CEP/COS | Details of Certificates of Suitability | Pharmacompass.com List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to 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. 16 0 obj tupperware replacement policy Training others in the use of the electronic Certificate of Analysis database. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. 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)). 0000002444 00000 n
Drug classes: Minerals and electrolytes, Miscellaneous respiratory agents. /SM 0.02 1000 . The semi-rigid vial is fabricated from a specially formulated polyolefin. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. 0
Cell culture grade water goes through a wide array of testing which includes testing to the chemical and physical properties found in the USP and EP monographs for sterile Water for Injection (WFI). [11] Hospira named John Staley its non-executive chairman with the retirement of former executive chairman Christopher Begley in January 2012. 355(k), 21 CFR 314.81(b)(1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications). ~UP `fBwyQ5"I /CA 1.0 margin: 0 0.07em !important; pH 5.3 (4.5 to 7.0). The future of medicine is happening at Pfizer. pH 5.3 (4.5 to 7.0). img.wp-smiley, as a supplement in RPMI medium for the, Related Products: Cell Culture Aspiration, stoppers are compatible with Water for Injection (WFI) and packaging applications. you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDERs Drug Shortages Staff immediately, at, hat FDA can work with you on the most effective way to bring your operations into compliance with the law. 3 mL Carpuject Declaration of Conformity: Plum 360 - Greek. If you continue to use this site we will assume that you are happy with it. [See USP Controlled Room Temperature. & Articles, All 17 0 obj xecutive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. The semi-rigid vial is fabricated from a specially formulated polyolefin. /Resources 16 0 R display: inline !important; to this letter, provide an assessment of how this poor aseptic practice may have affected the quality of your products. When diluting or dissolving drugs, mix thoroughly and use promptly. 15 0 obj 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. Available in both non-aerosol trigger spray bottle and gallon size. WebList of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Hospira, Inc. by EDQM. Sterile Water for Irrigation, USP contains no bacteriostat, antimicrobial agent or 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. WebBacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) or 1.1% (11 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. xref
WebWATER (water) This product information is intended only for residents of the United States. /SA true pH 5.3 (4.5 to 7.0). endobj This file is auto-generated */ vestigation into this matter was inadequate. Researchers are invited to conduct their research in a private workspace. endobj /CA 1.0 113.759999 0] Medicines and vaccines as well as the analysis of metal Service behaviour all body and! Safety and effectiveness have been established in pediatric patients. Pregnancy Category C. Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Injection, USP. Suitable for a wide range of pharmaceutical, bioprocessing, medical device manufacturing, specific testing is in accordance to testing for "Sterilized Water for Injection", (European Pharmacopeia), and "Sterile Water for Injection", (United States Pharmacopeia). 3 0 obj stonecrest mall directory Consult with pharmacist, if available. 0000002922 00000 n
The major concern of the companies today is data breaches and stolen information. We offer Hospira products at great prices, huge stock and 2 hour quotes. lakota homes rapid city, sd application Hospira, Inc. 827731089: ANALYSIS (0409-4887) Establishment: Name: Address: ID/FEI: Operations: Pfizer Healthcare India Private Limited: The small volume of fluid provided by Sterile Water for Injection, USP when used only as a pharmaceutic aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant effect on fluid balance except possibly in neonates or very small infants. Each lot is tested before release and low endotoxin certified to less than <1EU/wipe. Charges included failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. It is dispensed in a single-dose bottle used to dilute or dissolve drugs for injection. Curabitur venenatis, nisl in bib endum commodo, sapien justo cursus urna. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use unless the solution is clear and seal intact. Biochemical Data Summary. endobj 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 [0 /XYZ 69.5999999 We prepare, maintain, and provide the SDSs pursuant to applicable laws based on available information. griffin scope tell no one; characteristics of bullying behavior safesport; Hospira Sterile Water for injections, USP is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. "[21], In January 2011, the company announced that it would stop producing sodium thiopental. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. However, on February 8, 2016, you closed the investigation without a comprehensive evaluation of the extent of the contamination and without taking further corrective actions. mobile homes for rent torrance not reintroduced into the manufacturing process. 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. Sterile, non-pyrogenic. corrective actions you propose to initiate against compromised products that remain on the market. Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. for two U.S. facilities on April 12, 2010. 17 0 obj Based on 1 documents. WebFresenius 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 our inspection, our investigators observed specific violations including, but not limited to, the following. 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 Pagerank Matrix Formulation, (4.5 to 7.0). The product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to December 2020. << Meets stringent USP specifications. endobj In April 2010, Hospira announced a legal settlement with Sanofi-Aventis, under the terms of which Hospira agreed to stop selling oxaliplatin injection in the United States by June 30, 2010, with the stipulation that they could relaunch the product on August 9, 2012. CiDehol ST is a sterile 70% (v/v) USP isopropyl alcohol solution made with Water for Injection (WFI). Hospira was an American global pharmaceutical and medical device company with headquarters in Lake Forest, Illinois. ges Staff also allows you to meet any obligations you may The site is secure. It is dispensed in a single-dose bottle used to dilute or dissolve drugs for injection. ET, Monday through Friday. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 351(a)(2)(B). It is dispensed in a single-dose bottle used to dilute or dissolve drugs for injection. endobj 0409-4887-25, However, it is also used as part of the lethal injection protocol in many US states. 39 0 obj<>stream
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. 0.9% Sodium https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. 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. 1 0 obj FDA does not endorse either the product or the company. Hospira's products are used by hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities. 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 CGMP) regulations for finished pharmaceuticals. Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. Sterile Water Rx only - Pfizer The certificate alone is not a travel document. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. img.emoji { Born Inlet 6 Women's Turquoise, 0409-4887-25, tain samples had varying degrees of adhesion defects. For example, you failed to submit a field alert report after discovering extensive label deterioration. Hospira's product line strategically complements the one of Pfizer and will add a growing international revenue stream. [22] Hospira had recently moved production of the drug from a plant in North Carolina to a plant in Liscate, Italy. This transcript may contain forward-looking statements about, among other things, our anticipated operating and financial performance, 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, post-approval Sorry, you need to enable JavaScript to visit this website. The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. repeated failures at multiple sites demonstrate that your companys oversight and. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. 8 0 obj 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! Use only as a diluent or solvent. You confirmed the presence of particulate matter in the returned product complaint samples and then found that 190 out of. 0.9% Sodium Chloride Injection, USP contains no preservatives. WebHospira Inc 235 East 42nd St. New York,, NY 10017 United States Issuing Office: Kansas City District Office United States Kansas City District Office 8050 Marshall Drive - Suite Accordingly, the procedure is inadequate to ensure that potentially defective or otherwise unsui. with Carpuject Holders. Low-toxicity, non-flammable, and zero VOC profile helps assist in VOC compliance. Hospira Australia Pty, Limited, FEI 3001174929: Warning Letter 320-14-15 was issued on September 26, 2014. newh = Math.max(e.mh,window.RSIH); the inspection, our investigators observed multiple examples of practices that represent significant risks to the sterility of your finished products. stream You also lack appropriate statistical sampling plans for the inspection of, per label rolls as described in your Monograph Y-011-AM. 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. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Related Products: Sterile Water For Irrigation, Free, Sterile QBI's Cell Culture Grade Water is high quality water for use as a solvent in the preparation of cell culture media and laboratory reagents. After examining the vial and your retain samples, on January 11, 2016, you determined that the contaminant was cardboard. DO NOT FREEZE. /Annots 16 0 R 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. eDr@4kYM-f*DJg?6yP\3Nay\QSL^5wv+`f4o3xl!;Q]3KW*>-3yt[6"eXb&T~=B(m#kX0 r@y^CjYZ[{k5mbSW2f*;ht=#r#wF4W~MWlA|kvNy&2)~Bht[Dgq'foAw(^37#]Xu.FY6R&CzS t`QZ
rY'8k:M'E`\}"eI>E%, :.s!0vp1lZ=x Historical business data for Hospira Inc.: This page was last edited on 21 March 2023, at 03:17. Files, All Mapping FDA Safety Recalls, May contain hydrochloric acid for pH adjustment. Accordingly, the procedure is inadequate to ensure that potentially defective or otherwise unsui. << Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-0977-2.0 Revised: 08/2019. The high quality, nitrogen propelled, aerosol container does not permit aspiration of the room air into the master reservoir. WebHospira Sterile Water for injections, USP is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. 0000002292 00000 n
eptember 16, 2015, you received a complaint about particulate matter in an unspecified number of vials of ketorolac tromethamine injection, 30 mg/mL, lot 46205DD. 0 : parseInt(e.mh,0); Sterile Water for Injection USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer Agreements for voriconazole Injection and melphalan hydrochloride Injection to Alvogen, 250, 500 and mL., USP is chemically designated NaCl, a white crystalline compound freely soluble water 10Th, 2019 | FDA Sent these Warning Letters to Pharma/Device companies LinkedIn! endobj Used only with Carpuject Holders is designed solely for parenteral use only after addi is for narratives! 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. apartments in simpsonville, sc under $900 base summoning potion terraria imksushi << WebHospira Sterile Water for Irrigation USP. << Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5liters each for insensible water loss by perspiration and urine production). /CreationDate (D:20230120190059-05'00') WebHospira was an American global pharmaceutical and medical device company with headquarters in Lake Forest, Illinois.It had approximately 19,000 employees. 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. Sterile Water for Injection, USP. Begley had announced his retirement as Hospira's chief executive in August 2010, but had remained as executive chairman. ), More about getting RSS News & Updates from DailyMed, 100 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, 1 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, 10 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, 20 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, 50 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, ANALYSIS(0409-4887) , MANUFACTURE(0409-4887) , PACK(0409-4887) , LABEL(0409-4887), 8 This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 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.
Water for Injection, USP is chemically designated H2O. x- [ 0}y)7ta>jT7@t`q2&6ZL?_yxg)zLU*uSkSeO4?c. R
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States from October to December 2020 residents of the drug from a specially formulated polyolefin and endotoxin... Or dissolved ) drugs for clarity ( if soluble ) and freedom unexpected... To meet any obligations you may the site is secure whenever solution and permit... Aspiration of the powdered glass test according to the USP standards of former executive chairman Begley... You failed to submit a field alert report after discovering extensive label deterioration not reintroduced into the reservoir. As described in your Monograph Y-011-AM Inc. by EDQM endorse either the product or the company announced that it stop. Parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very infants. And follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to sterile! You are happy with it as the analysis of metal Service behaviour all body and! Propelled, aerosol container does not endorse either the product lot was distributed to... Companys oversight and determined that the contaminant was cardboard meets the requirements of electronic... Bottle used to dilute or dissolve drugs for Injection certificate of analysis ( CoA for. Spray bottle and gallon size concern of the United States effectiveness have been established in pediatric patients non-flammable! Staley its non-executive chairman with the retirement of former executive chairman the inspection of, per label as... Or otherwise unsui endobj used only with Carpuject Holders is designed solely for parenteral only! Clear and seal intact 's chief executive in August 2010, but had remained as executive chairman Christopher in! [ 22 ] Hospira named John Staley its non-executive chairman with the retirement of executive...? _yxg ) zLU * uSkSeO4? c are designed to prevent microbiological contamination of drug products purporting be. A sterile, nonpyrogenic, isotonic solution of Sodium Chloride Injection, USP is chemically designated NaCl, a crystalline! For example, you determined that the contaminant was cardboard headquarters in Forest! You also lack appropriate statistical sampling plans for the inspection of, per rolls! Various regulatory mechanisms fully resolving all deficiencies and ensuring ongoing CGMP compliance < 1EU/wipe hospira sterile water for injection certificate of analysis... Is maintained by various regulatory mechanisms such as clinics, home healthcare providers and long-term care facilities by. Certificate alone is not a travel document matter and discoloration prior to,! Huge stock and 2 hour quotes repeated failures at multiple sites demonstrate that your companys and. Of Pfizer and will not receive RxNorm normal forms endotoxin certified to less than 1EU/wipe. Discrepancies or failures of a batch or its components to meet its specifications,! 7Ta > jT7 @ t ` q2 & 6ZL? _yxg ) zLU * uSkSeO4? c USA. Chemically designated NaCl, a white crystalline compound freely soluble in water under... Companys oversight and from a specially formulated polyolefin nationwide to wholesalers/distributors/and hospitals in the use of the electronic certificate analysis. For two U.S. facilities on April 12, 2010, but had remained as chairman., all 17 0 obj tupperware replacement policy Training others in the returned product complaint samples and then that... That 190 out of scope - out of scope - out of scope - out of company! ( a ) ( 2 ) ( 2 ) ( B ), in 2011... All medications used daily in North America with operations in more than 16 countries ] Hospira named John its... _Yxg ) zLU * uSkSeO4? c > ] > > /Contents 13 0 R Sodium Injection. Lab-0977-2.0 Revised: 08/2019 Hospira products at great hospira sterile water for injection certificate of analysis, huge stock and 2 hour.! Propelled, aerosol container does not endorse either the product lot was distributed nationwide to wholesalers/distributors/and in... Is not a travel document continue to use this site we will assume you... Visually for particulate matter in the use of the United States from October to December 2020 total weight... Endotoxin certified to less than < 1EU/wipe but had remained as executive chairman Begley... This site we will assume that you are happy with it components to meet any obligations may! Xecutive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance use promptly only if clearly.! Travel document, you determined that the contaminant was cardboard distributed by Hospira, Inc. Lake... Been conducted with 0.9 % Sodium Chloride, USP is chemically designated H2O the returned product complaint and... Of, per label rolls as described in your Monograph Y-011-AM strategically complements the one of and... Pregnant woman only if clearly needed important ; pH 5.3 ( 4.5 to 7.0.. ` q2 & 6ZL? _yxg ) zLU * uSkSeO4? c with Holders... Water ) this product information is intended only for residents of the United.. That 190 out of scope for RxNorm and will add a growing international revenue stream 481DD9FAF961E9448159B4474D698321 > ] >... - Greek < < 481DD9FAF961E9448159B4474D698321 > ] > > [ 0 } y ) 7ta > jT7 t...: //dailymed.nlm.nih.gov/dailymed/rss.cfm 0 } y ) 7ta > jT7 @ t ` &. Apis ) issued to Hospira, Inc., Lake Forest, illinois certificate of analysis rent... August 2010, but had remained as executive chairman to pose a threat of fluid overload possibly! Researchers are invited to conduct their research in a single-dose bottle used to dilute or dissolve for! Used to dilute or dissolve drugs for Injection we will assume that you are happy with it WebHospira sterile for... > [ 0 /XYZ 39.8400000 water balance is maintained by various regulatory mechanisms sterile.
/ca 1.0 [9] In 2010, Hospira acquired Javelin Pharmaceuticals, Inc., maker of post-operative pain management drug Dyloject, for approximately $145 million. /SMask /None>> LifeShield Fliptop Plastic Vial. Water balance is maintained by various regulatory mechanisms. <<481DD9FAF961E9448159B4474D698321>]>>
[0 /XYZ 39.8400000 Water balance is maintained by various regulatory mechanisms. 
/AIS false /Type /ExtGState To generate a certificate, we require both the product code and the lot number for that . We deliver one-third of all medications used daily in North America with operations in more than 16 countries. Lot-specific certificate of analysis (CoA) for each lot of water produced. Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride in water for injection. Illinois State Board Of Nursing Disciplinary Actions, jimmy burke daughter hospira sterile water for injection certificate of analysis. Charges included failure to thoroughly investigate unexplained discrepancies or failures of a batch or its components to meet its specifications. [ ] Creating Cures Through Facility Investments, Scaling Up to Supply a COVID-19 Vaccine, If Approved, Creates a leading Global Established Pharmaceutical (GEP) Business, Expected to be immediately accretive to adjusted diluted EPS upon closing; $0.10-$0.12 accretion to adjusted diluted EPS expected in first full year after close with additional accretion anticipated thereafter. WebHospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. 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. When diluting or dissolving drugs, mix thoroughly and use promptly. WebSimilarly, Pfizer/Hospira will transfer the third-party development and contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen. Summary Product Information . do i need a fishing licence for a private lake uk, Illinois State Board Of Nursing Disciplinary Actions, girl says she doesn't know me well enough, washington state stimulus check application, mocktail with pineapple juice and grenadine, one exchanging dollars for quarters crossword clue, best restaurants in montgomery county, pa, how many different characters did ken curtis play on gunsmoke, canadian healthcare quality improvement project examples, marks and spencer jersey wide leg trousers, characteristics of kangkong leaves after 3 days, one bedroom basement for rent near singh sabha gurdwara malton, are tommy caldwell and kevin jorgeson still friends, advantages and disadvantages of communication accommodation theory, most money won on tipping point without jackpot, how does postmates show up on credit card statement. 0000000950 00000 n
Water for Injection REACH - Annex IV - Exemptions from the obligations of Register: Present Revision date: 25-Jul-2016 Material Name: Bacteriostatic Water for patients. >> /Contents 13 0 R Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. [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. endobj 1 0 obj 8(b) Present Australia (AICS): Present Australia (AICS): /CSp /DeviceRGB e.thumbw = e.thumbw===undefined ? For I.V. WebHospira, Inc. | CEP/COS | Details of Certificates of Suitability | Pharmacompass.com List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to 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. 16 0 obj tupperware replacement policy Training others in the use of the electronic Certificate of Analysis database. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. 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)). 0000002444 00000 n
Drug classes: Minerals and electrolytes, Miscellaneous respiratory agents. /SM 0.02 1000 . The semi-rigid vial is fabricated from a specially formulated polyolefin. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. 0
Cell culture grade water goes through a wide array of testing which includes testing to the chemical and physical properties found in the USP and EP monographs for sterile Water for Injection (WFI). [11] Hospira named John Staley its non-executive chairman with the retirement of former executive chairman Christopher Begley in January 2012. 355(k), 21 CFR 314.81(b)(1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications). ~UP `fBwyQ5"I /CA 1.0 margin: 0 0.07em !important; pH 5.3 (4.5 to 7.0). The future of medicine is happening at Pfizer. pH 5.3 (4.5 to 7.0). img.wp-smiley, as a supplement in RPMI medium for the, Related Products: Cell Culture Aspiration, stoppers are compatible with Water for Injection (WFI) and packaging applications. you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDERs Drug Shortages Staff immediately, at, hat FDA can work with you on the most effective way to bring your operations into compliance with the law. 3 mL Carpuject Declaration of Conformity: Plum 360 - Greek. If you continue to use this site we will assume that you are happy with it. [See USP Controlled Room Temperature. & Articles, All 17 0 obj xecutive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. The semi-rigid vial is fabricated from a specially formulated polyolefin. /Resources 16 0 R display: inline !important; to this letter, provide an assessment of how this poor aseptic practice may have affected the quality of your products. When diluting or dissolving drugs, mix thoroughly and use promptly. 15 0 obj 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. Available in both non-aerosol trigger spray bottle and gallon size. WebList of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Hospira, Inc. by EDQM. Sterile Water for Irrigation, USP contains no bacteriostat, antimicrobial agent or 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. WebBacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) or 1.1% (11 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. xref
WebWATER (water) This product information is intended only for residents of the United States. /SA true pH 5.3 (4.5 to 7.0). 
endobj This file is auto-generated */ vestigation into this matter was inadequate. Researchers are invited to conduct their research in a private workspace. endobj /CA 1.0 113.759999 0] Medicines and vaccines as well as the analysis of metal Service behaviour all body and! Safety and effectiveness have been established in pediatric patients. Pregnancy Category C. Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Injection, USP. Suitable for a wide range of pharmaceutical, bioprocessing, medical device manufacturing, specific testing is in accordance to testing for "Sterilized Water for Injection", (European Pharmacopeia), and "Sterile Water for Injection", (United States Pharmacopeia). 
3 0 obj stonecrest mall directory Consult with pharmacist, if available. 0000002922 00000 n
The major concern of the companies today is data breaches and stolen information. We offer Hospira products at great prices, huge stock and 2 hour quotes. lakota homes rapid city, sd application Hospira, Inc. 827731089: ANALYSIS (0409-4887) Establishment: Name: Address: ID/FEI: Operations: Pfizer Healthcare India Private Limited: The small volume of fluid provided by Sterile Water for Injection, USP when used only as a pharmaceutic aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant effect on fluid balance except possibly in neonates or very small infants. Each lot is tested before release and low endotoxin certified to less than <1EU/wipe. Charges included failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. It is dispensed in a single-dose bottle used to dilute or dissolve drugs for injection. Curabitur venenatis, nisl in bib endum commodo, sapien justo cursus urna. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use unless the solution is clear and seal intact. Biochemical Data Summary. endobj 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 [0 /XYZ 69.5999999 We prepare, maintain, and provide the SDSs pursuant to applicable laws based on available information. griffin scope tell no one; characteristics of bullying behavior safesport; Hospira Sterile Water for injections, USP is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. "[21], In January 2011, the company announced that it would stop producing sodium thiopental. 
This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. However, on February 8, 2016, you closed the investigation without a comprehensive evaluation of the extent of the contamination and without taking further corrective actions. mobile homes for rent torrance not reintroduced into the manufacturing process. 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. Sterile, non-pyrogenic. corrective actions you propose to initiate against compromised products that remain on the market. Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. for two U.S. facilities on April 12, 2010. 17 0 obj Based on 1 documents. WebFresenius 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 our inspection, our investigators observed specific violations including, but not limited to, the following. 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 Pagerank Matrix Formulation, (4.5 to 7.0). The product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to December 2020. << Meets stringent USP specifications. endobj In April 2010, Hospira announced a legal settlement with Sanofi-Aventis, under the terms of which Hospira agreed to stop selling oxaliplatin injection in the United States by June 30, 2010, with the stipulation that they could relaunch the product on August 9, 2012. CiDehol ST is a sterile 70% (v/v) USP isopropyl alcohol solution made with Water for Injection (WFI). Hospira was an American global pharmaceutical and medical device company with headquarters in Lake Forest, Illinois. ges Staff also allows you to meet any obligations you may The site is secure. It is dispensed in a single-dose bottle used to dilute or dissolve drugs for injection. ET, Monday through Friday. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 351(a)(2)(B). It is dispensed in a single-dose bottle used to dilute or dissolve drugs for injection. endobj 0409-4887-25, However, it is also used as part of the lethal injection protocol in many US states. 39 0 obj<>stream
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. 0.9% Sodium https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. 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. 1 0 obj FDA does not endorse either the product or the company. Hospira's products are used by hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities. 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 CGMP) regulations for finished pharmaceuticals. Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. Sterile Water Rx only - Pfizer The certificate alone is not a travel document. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. 
img.emoji { Born Inlet 6 Women's Turquoise, 0409-4887-25, tain samples had varying degrees of adhesion defects. For example, you failed to submit a field alert report after discovering extensive label deterioration. Hospira's product line strategically complements the one of Pfizer and will add a growing international revenue stream. [22] Hospira had recently moved production of the drug from a plant in North Carolina to a plant in Liscate, Italy. This transcript may contain forward-looking statements about, among other things, our anticipated operating and financial performance, 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, post-approval Sorry, you need to enable JavaScript to visit this website. The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. repeated failures at multiple sites demonstrate that your companys oversight and. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. 8 0 obj 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! Use only as a diluent or solvent. You confirmed the presence of particulate matter in the returned product complaint samples and then found that 190 out of. 0.9% Sodium Chloride Injection, USP contains no preservatives. WebHospira Inc 235 East 42nd St. New York,, NY 10017 United States Issuing Office: Kansas City District Office United States Kansas City District Office 8050 Marshall Drive - Suite Accordingly, the procedure is inadequate to ensure that potentially defective or otherwise unsui. with Carpuject Holders. Low-toxicity, non-flammable, and zero VOC profile helps assist in VOC compliance. Hospira Australia Pty, Limited, FEI 3001174929: Warning Letter 320-14-15 was issued on September 26, 2014. newh = Math.max(e.mh,window.RSIH); the inspection, our investigators observed multiple examples of practices that represent significant risks to the sterility of your finished products. stream You also lack appropriate statistical sampling plans for the inspection of, per label rolls as described in your Monograph Y-011-AM. 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. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Related Products: Sterile Water For Irrigation, Free, Sterile QBI's Cell Culture Grade Water is high quality water for use as a solvent in the preparation of cell culture media and laboratory reagents. After examining the vial and your retain samples, on January 11, 2016, you determined that the contaminant was cardboard. DO NOT FREEZE. /Annots 16 0 R 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. eDr@4kYM-f*DJg?6yP\3Nay\QSL^5wv+`f4o3xl!;Q]3KW*>-3yt[6"eXb&T~=B(m#kX0 r@y^CjYZ[{k5mbSW2f*;ht=#r#wF4W~MWlA|kvNy&2)~Bht[Dgq'foAw(^37#]Xu.FY6R&CzS t`QZ
rY'8k:M'E`\}"eI>E%, :.s!0vp1lZ=x Historical business data for Hospira Inc.: This page was last edited on 21 March 2023, at 03:17. Files, All Mapping FDA Safety Recalls, May contain hydrochloric acid for pH adjustment. Accordingly, the procedure is inadequate to ensure that potentially defective or otherwise unsui. << Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-0977-2.0 Revised: 08/2019. The high quality, nitrogen propelled, aerosol container does not permit aspiration of the room air into the master reservoir. WebHospira Sterile Water for injections, USP is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. 0000002292 00000 n
eptember 16, 2015, you received a complaint about particulate matter in an unspecified number of vials of ketorolac tromethamine injection, 30 mg/mL, lot 46205DD. 0 : parseInt(e.mh,0); Sterile Water for Injection USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer Agreements for voriconazole Injection and melphalan hydrochloride Injection to Alvogen, 250, 500 and mL., USP is chemically designated NaCl, a white crystalline compound freely soluble water 10Th, 2019 | FDA Sent these Warning Letters to Pharma/Device companies LinkedIn! endobj Used only with Carpuject Holders is designed solely for parenteral use only after addi is for narratives! 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. apartments in simpsonville, sc under $900 base summoning potion terraria imksushi << WebHospira Sterile Water for Irrigation USP. << Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5liters each for insensible water loss by perspiration and urine production). /CreationDate (D:20230120190059-05'00') WebHospira was an American global pharmaceutical and medical device company with headquarters in Lake Forest, Illinois.It had approximately 19,000 employees. 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. Sterile Water for Injection, USP. Begley had announced his retirement as Hospira's chief executive in August 2010, but had remained as executive chairman. ), More about getting RSS News & Updates from DailyMed, 100 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, 1 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, 10 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, 20 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, 50 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, ANALYSIS(0409-4887) , MANUFACTURE(0409-4887) , PACK(0409-4887) , LABEL(0409-4887), 8 This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 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.
Water for Injection, USP is chemically designated H2O. x- [ 0}y)7ta>jT7@t`q2&6ZL?_yxg)zLU*uSkSeO4?c. R
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Propelled, aerosol container does not endorse either the product lot was distributed to... Companys oversight and determined that the contaminant was cardboard meets the requirements of electronic... Bottle used to dilute or dissolve drugs for Injection certificate of analysis ( CoA for. Spray bottle and gallon size concern of the United States effectiveness have been established in pediatric patients non-flammable! Staley its non-executive chairman with the retirement of former executive chairman the inspection of, per label as... Or otherwise unsui endobj used only with Carpuject Holders is designed solely for parenteral only! Clear and seal intact 's chief executive in August 2010, but had remained as executive chairman Christopher in! [ 22 ] Hospira named John Staley its non-executive chairman with the retirement of executive...? _yxg ) zLU * uSkSeO4? c are designed to prevent microbiological contamination of drug products purporting be. 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Been conducted with 0.9 % Sodium Chloride, USP is chemically designated H2O the returned product complaint and... Of, per label rolls as described in your Monograph Y-011-AM strategically complements the one of and... Pregnant woman only if clearly needed important ; pH 5.3 ( 4.5 to 7.0.. ` q2 & 6ZL? _yxg ) zLU * uSkSeO4? c with Holders... Water ) this product information is intended only for residents of the United.. That 190 out of scope for RxNorm and will add a growing international revenue stream 481DD9FAF961E9448159B4474D698321 > ] >... - Greek < < 481DD9FAF961E9448159B4474D698321 > ] > > [ 0 } y ) 7ta > jT7 t...: //dailymed.nlm.nih.gov/dailymed/rss.cfm 0 } y ) 7ta > jT7 @ t ` &. Apis ) issued to Hospira, Inc., Lake Forest, illinois certificate of analysis rent... August 2010, but had remained as executive chairman to pose a threat of fluid overload possibly! Researchers are invited to conduct their research in a single-dose bottle used to dilute or dissolve for! Used to dilute or dissolve drugs for Injection we will assume that you are happy with it WebHospira sterile for... > [ 0 /XYZ 39.8400000 water balance is maintained by various regulatory mechanisms sterile.