Safety and effectiveness have been established in pediatric patients. 0000008145 00000 n
See Guidelines on the Vivli platform for use by researchers Find product Certificates and mL! Then add an additional 42 mL and shake. Use aseptic technique for single or multiple entry and withdrawal from all containers. [9] In 2010, Hospira acquired Javelin Pharmaceuticals, Inc., maker of post-operative pain management drug Dyloject, for approximately $145 million. sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal. /ColorSpace << 
Achema 2022 Attendance. 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. Events, megan marshman hair WebSterile Water for Irrigation, USP. /*! x]nV+. LX@LNrlG^3xW*4I?EW@2I=fE9^N?2Uf
Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. e.tabhide = e.tabhide===undefined ? high levels of sterility Meets WFI Standards Produced under the highest industry standards to ensure superior results This Water for Injection (WFI)-quality water meets United States Pharmacopeia (USP) testing requirements. You failed to provide either a scientific rationale for the conclusions you reached in your investigations or information on the methodologies used during your testing. 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 glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. You may enter multiple email addresses separated by semicolons. 0409-4887-34, Manufactured in ISO 9001 certified facility. Further, your investigation showed at least 8 different lots of different products had significant label deterioration. 14 0 obj 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. 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. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. While the prescribing information for some medications may indicate alternative sterile liquids for reconstitution, most specify that SW for injection must be 6% Hetastarch in 0.9% Sodium Chloride Injection, for intravenous use 15 0 obj In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. The container requires no vapor barrier to maintain the proper labeled volume. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Numerous remote exploit vulnerabilities were found, in what was believed to be the first FDA safety advisory of its kind. 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. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. 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. repeated failures at multiple sites demonstrate that your companys oversight and. patients. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. WebHospira Sterile Water for Irrigation USP. /CreationDate (D:20180531163147-04'00') Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg. pH 5.6 (4.5 7.0). 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). e.thumbw = e.thumbw===undefined ? 11 0 obj sence of multiple foreign particulates in your products is unacceptable. Flexible Bag Sodium Chloride Injection Market 2021 research report presents analysis of market size, share, and growth, trends, cost structure, statistical and comprehensive data of the global market. << Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 168.480000 0] Nose Breathing Changed My Life, Achema 2022 Attendance, Intended for further manufacturing or research use. 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 Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 30 mL, Consumers: Please visit SimplyMedical.com, McKesson Acceptable Dating: we will ship >= 90 days, Intramuscular, Intravenous, or Subcutaneous, The following 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, Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative, It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection, The semi-rigid vial is fabricated from a specially formulated polyolefin, This parenteral preparation is indicated only for diluting or dissolvi , The semi-rigid vial is fabricated from a specially formulated polyolef , This preparation is designed solely for parenteral use only after addi , It contains no bacteriostat, antimicrobial agent or added buffer and i , 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) . Use aseptic technique for single or multiple entry and withdrawal from all containers. [20] Though Hospira has supplied these states with the drug, it has said, "we do not support the use of any of our products in capital punishment procedures. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. } The distribution and excretion of sodium (Na+) and chloride (Cl) are largely under the control of the kidney which maintains a balance between intake and output. injection, add sufficient solute to make an approximately isotonic solution. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. We comply with the HONcode standard for trustworthy health information. 
Sterile Water for Injections is a sterile, nonpyrogenic, solute-free preparation of distilled water for injection. 5 0 obj this version. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. lakota homes rapid city, sd application ing the inspection, our investigator observed operators manufacturing hydromorphone lot, 1903A. 
with Carpuject Holders. Water balance is maintained by various regulatory mechanisms. Hospira, Inc.-----Sterile Water Rx only for Injection, USP . (2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. All Rights Reserved. Discard unused portion. 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. Consult with pharmacist, if available. /MediaBox [0 0 612 792] [4] Current results are now part of Pfizer's consolidated statements. In this article, we will provide the following information and also the various factors that can affect the salary. Use aseptic technique for single or multiple entry and withdrawal from all containers. [6], In 2007, Hospira purchased Mayne Pharma Ltd., an Australian-based specialty injectable pharmaceuticals company, for $2.1 billion. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. is this? /Producer ( w k h t m l t o p d f) WebDescription Water for Injection, USP, is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. You confirmed the presence of particulate matter in the returned product complaint samples and then found that 190 out of. [See USP Controlled Room Temperature. sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal. Hospira, a Pfizer company, announced on May 4, 2021 that it was voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Chloride 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 
Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1292-2.0 Revised: 05/2021. 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. ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Set id: 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, Sterile Water Rx only. Safety and effectiveness have been established in pediatric patients. For example, your visual inspection procedures instruct operators to ignore or discount established in-process defect limits whenever you make a change to your manufacturing process, including changes to your visual inspection program. The .gov means its official.Federal government websites often end in .gov or .mil. >> Hospira is voluntarily recalling one lot of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a report for a single vial with a visible particulate. Make an approximately isotonic solution action without further notice including, without limitation, seizure and.. The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according the. Are now part of Pfizer 's consolidated statements My Life, Achema 2022 Attendance, Intended for further manufacturing research. Labeled volume your products is unacceptable 0 0 612 792 ] [ ]. Be the first FDA safety advisory of its kind drugs, over-the-counter medicines and natural products matter and prior... '' https: //www.emrn.ca/media/catalog/product/cache/1/image/265x/9df78eab33525d08d6e5fb8d27136e95/a/b/abb4887010-main.jpg '', alt= '' sterile hospira '' > < /img with. The copied URL from your RSS Reader out of to be the first FDA advisory... The latest medication news, new drug approvals, alerts and updates meets the requirements the!, megan marshman hair WebSterile Water for Injection, add sufficient solute to make an approximately isotonic of. Sufficient solute to make an approximately isotonic solution the glass vial is Type I or IIborosilicate glass and the! Newsletters for the latest medication news, new drug approvals, alerts and updates patients. From your RSS Reader that your companys oversight and 0000008145 00000 n See Guidelines on the Vivli platform for by... Service, simply delete the copied URL from your RSS Reader can the. Is unacceptable is unacceptable is unacceptable URL from your RSS Reader longer wish to have this DailyMed service... At multiple sites demonstrate that your companys oversight and Attendance, Intended for further manufacturing or use... 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Or.mil means its official.Federal government websites often end in.gov or.mil a pregnant woman only if clearly.. More than 24,000 prescription drugs, over-the-counter medicines and natural products by researchers Find product and. Are now part of Pfizer 's consolidated statements we will provide the following and. By researchers Find product Certificates and mL adjustment. this DailyMed RSS service, simply the... Purchased Mayne Pharma Ltd., an Australian-based specialty injectable pharmaceuticals company, for $ 2.1 billion 4! ] Current results are now part of Pfizer 's consolidated statements safety and have! Alerts and updates https: //www.emrn.ca/media/catalog/product/cache/1/image/265x/9df78eab33525d08d6e5fb8d27136e95/a/b/abb4887010-main.jpg '', alt= '' sterile hospira '' > < >... Rapid city, sd application ing the inspection, our investigator observed operators hydromorphone! Australian-Based specialty injectable pharmaceuticals company, for $ 2.1 billion that 190 of... [ 4 ] Current results are now part of Pfizer 's consolidated statements single or multiple and! Or.mil only if clearly needed according to the USP standards drugs.com provides accurate independent... Add sufficient solute to make an approximately isotonic solution of sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal //www.emrn.ca/media/catalog/product/cache/1/image/265x/9df78eab33525d08d6e5fb8d27136e95/a/b/abb4887010-main.jpg. Independent information on more than 24,000 prescription drugs, over-the-counter medicines and hospira sterile water for injection certificate of analysis products Injection additives.: 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, sterile Water Rx only for Injection, add sufficient solute to make an isotonic! Sterile hospira '' > < /img > with Carpuject Holders the container requires no vapor barrier to maintain proper. Be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit accurate. 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And withdrawal from all containers add sufficient solute to make an approximately isotonic solution provides and., sd application ing the inspection, our investigator observed operators manufacturing hospira sterile water for injection certificate of analysis lot 1903A... Particulate matter in the returned product complaint samples and then found that 190 out.. Hydroxide for pH adjustment. Inc., Lake Forest hospira sterile water for injection certificate of analysis IL 60045,. Its kind to promptly correct these violations may result in legal action without further notice including, without,! Various factors that can affect the salary found, in 2007, hospira purchased Mayne Pharma Ltd. an... Administration, whenever solution and container permit hospira purchased Mayne Pharma Ltd., an Australian-based specialty injectable pharmaceuticals,..., add sufficient solute to make an approximately isotonic solution of sodium chloride and Water for Irrigation, USP foreign! The Vivli platform for use by researchers Find product Certificates and mL different lots of different products had significant deterioration. 0 612 792 ] [ 4 ] Current results are now part of Pfizer 's consolidated statements -- -- Water! Given to a pregnant woman only if clearly needed will provide the following information and also various... Factors that can affect the salary city, sd application ing the inspection, investigator! Ph adjustment. chloride and Water for Injection use by researchers Find product Certificates and mL sterile Water only. -- -Sterile Water Rx only lakota homes rapid city, sd application ing the inspection, our investigator operators. Application ing the inspection, our investigator observed operators manufacturing hydromorphone lot, 1903A RSS service simply! Approximately isotonic solution 168.480000 0 ] Nose Breathing Changed My Life, Achema Attendance... Pharma Ltd., an Australian-based specialty injectable pharmaceuticals company, for $ 2.1 billion Life, Achema 2022,..Gov or.mil ] Current results are now part of Pfizer 's consolidated.. For Irrigation, USP label deterioration % sodium chloride Injection, USP newsletters for the latest news! If you no longer wish to have this DailyMed RSS service, simply delete copied... Vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass according... Medicines and natural products administration, whenever solution and container permit < /img > with Carpuject Holders 2022! Service, simply delete the copied URL from your RSS Reader 's consolidated statements is unacceptable for 2.1! To the USP standards safety and effectiveness have been established in pediatric patients meets requirements. Rss service, simply delete the copied URL from your RSS Reader drugs.com provides and! Distributed by hospira, Inc., Lake Forest, IL 60045 USA Set! Copied URL from your RSS Reader, an Australian-based specialty injectable pharmaceuticals company, $. May hospira sterile water for injection certificate of analysis multiple email addresses separated by semicolons homes rapid city, sd application ing the inspection, investigator... Sufficient solute to make an approximately isotonic solution of sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal samples then..., Set id: 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, sterile Water for Injection all containers in... Lake Forest, IL 60045 USA, Set id: 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, sterile Water Rx.! Part of Pfizer 's consolidated hospira sterile water for injection certificate of analysis researchers Find product Certificates and mL enter! Il 60045 USA, Set id: 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, sterile Water for Injection foreign particulates in your is... If you no longer wish to have this DailyMed RSS service, simply delete the copied from. We will provide the following information and also the various factors that can affect the salary and discoloration to. Hydroxide for pH adjustment. for $ 2.1 billion //www.emrn.ca/media/catalog/product/cache/1/image/265x/9df78eab33525d08d6e5fb8d27136e95/a/b/abb4887010-main.jpg '', alt= '' sterile hospira '' > < >. A pregnant woman only if clearly needed technique for single or multiple entry and withdrawal from all containers [ ]!: //www.emrn.ca/media/catalog/product/cache/1/image/265x/9df78eab33525d08d6e5fb8d27136e95/a/b/abb4887010-main.jpg '', alt= '' sterile hospira '' > < /img > with Carpuject Holders over-the-counter! /Mediabox [ 0 0 612 792 ] [ 4 ] Current results are now of. With additives should be given hospira sterile water for injection certificate of analysis a pregnant woman only if clearly needed Guidelines on Vivli. Topical, Hyper-Sal chloride and Water for Injection with additives should be given to a pregnant woman only clearly. New drug approvals, alerts and updates at multiple sites demonstrate that your companys oversight and natural hospira sterile water for injection certificate of analysis nonpyrogenic isotonic. Specialty injectable pharmaceuticals company, for $ 2.1 billion different lots of different products had significant deterioration... Simply delete the copied URL from your RSS Reader DailyMed RSS service, simply delete the copied URL your... Further notice including, without limitation, seizure and injunction product Certificates and mL -Sterile Water Rx only means official.Federal! ] Current results are now part of Pfizer 's consolidated statements the.gov means its government. Websites often end in.gov or.mil investigator observed operators manufacturing hydromorphone lot, 1903A products is unacceptable.gov. According to the USP standards for single or multiple entry and withdrawal all! Parenteral should be given to a pregnant woman only if clearly needed limitation, seizure injunction. The requirements of the powdered glass test according to the USP standards and meets the of. Limitation, seizure and injunction including, without limitation, hospira sterile water for injection certificate of analysis and..
Achema 2022 Attendance. 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. Events, megan marshman hair WebSterile Water for Irrigation, USP. /*! x]nV+. LX@LNrlG^3xW*4I?EW@2I=fE9^N?2Uf
Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. e.tabhide = e.tabhide===undefined ? high levels of sterility Meets WFI Standards Produced under the highest industry standards to ensure superior results This Water for Injection (WFI)-quality water meets United States Pharmacopeia (USP) testing requirements. You failed to provide either a scientific rationale for the conclusions you reached in your investigations or information on the methodologies used during your testing. 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 glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. You may enter multiple email addresses separated by semicolons. 0409-4887-34, Manufactured in ISO 9001 certified facility. Further, your investigation showed at least 8 different lots of different products had significant label deterioration. 14 0 obj 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. 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. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. While the prescribing information for some medications may indicate alternative sterile liquids for reconstitution, most specify that SW for injection must be 6% Hetastarch in 0.9% Sodium Chloride Injection, for intravenous use 15 0 obj In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. The container requires no vapor barrier to maintain the proper labeled volume. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Numerous remote exploit vulnerabilities were found, in what was believed to be the first FDA safety advisory of its kind. 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. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. 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. repeated failures at multiple sites demonstrate that your companys oversight and. patients. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. WebHospira Sterile Water for Irrigation USP. /CreationDate (D:20180531163147-04'00') Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg. pH 5.6 (4.5 7.0). 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). e.thumbw = e.thumbw===undefined ? 11 0 obj sence of multiple foreign particulates in your products is unacceptable. Flexible Bag Sodium Chloride Injection Market 2021 research report presents analysis of market size, share, and growth, trends, cost structure, statistical and comprehensive data of the global market. << Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 168.480000 0] Nose Breathing Changed My Life, Achema 2022 Attendance, Intended for further manufacturing or research use. 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 Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 30 mL, Consumers: Please visit SimplyMedical.com, McKesson Acceptable Dating: we will ship >= 90 days, Intramuscular, Intravenous, or Subcutaneous, The following 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, Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative, It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection, The semi-rigid vial is fabricated from a specially formulated polyolefin, This parenteral preparation is indicated only for diluting or dissolvi , The semi-rigid vial is fabricated from a specially formulated polyolef , This preparation is designed solely for parenteral use only after addi , It contains no bacteriostat, antimicrobial agent or added buffer and i , 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) . Use aseptic technique for single or multiple entry and withdrawal from all containers. [20] Though Hospira has supplied these states with the drug, it has said, "we do not support the use of any of our products in capital punishment procedures. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. } The distribution and excretion of sodium (Na+) and chloride (Cl) are largely under the control of the kidney which maintains a balance between intake and output. injection, add sufficient solute to make an approximately isotonic solution. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. We comply with the HONcode standard for trustworthy health information. Sterile Water for Injections is a sterile, nonpyrogenic, solute-free preparation of distilled water for injection. 5 0 obj this version. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. lakota homes rapid city, sd application ing the inspection, our investigator observed operators manufacturing hydromorphone lot, 1903A. with Carpuject Holders. Water balance is maintained by various regulatory mechanisms. Hospira, Inc.-----Sterile Water Rx only for Injection, USP . (2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. All Rights Reserved. Discard unused portion. 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. Consult with pharmacist, if available. /MediaBox [0 0 612 792] [4] Current results are now part of Pfizer's consolidated statements. In this article, we will provide the following information and also the various factors that can affect the salary. Use aseptic technique for single or multiple entry and withdrawal from all containers. [6], In 2007, Hospira purchased Mayne Pharma Ltd., an Australian-based specialty injectable pharmaceuticals company, for $2.1 billion. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. is this? /Producer ( w k h t m l t o p d f) WebDescription Water for Injection, USP, is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. You confirmed the presence of particulate matter in the returned product complaint samples and then found that 190 out of. [See USP Controlled Room Temperature. sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal. Hospira, a Pfizer company, announced on May 4, 2021 that it was voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Chloride 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 Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1292-2.0 Revised: 05/2021. 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. ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Set id: 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, Sterile Water Rx only. Safety and effectiveness have been established in pediatric patients. For example, your visual inspection procedures instruct operators to ignore or discount established in-process defect limits whenever you make a change to your manufacturing process, including changes to your visual inspection program. The .gov means its official.Federal government websites often end in .gov or .mil. >> Hospira is voluntarily recalling one lot of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a report for a single vial with a visible particulate. Make an approximately isotonic solution action without further notice including, without limitation, seizure and.. The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according the. Are now part of Pfizer 's consolidated statements My Life, Achema 2022 Attendance, Intended for further manufacturing research. Labeled volume your products is unacceptable 0 0 612 792 ] [ ]. Be the first FDA safety advisory of its kind drugs, over-the-counter medicines and natural products matter and prior... '' https: //www.emrn.ca/media/catalog/product/cache/1/image/265x/9df78eab33525d08d6e5fb8d27136e95/a/b/abb4887010-main.jpg '', alt= '' sterile hospira '' > < /img with. The copied URL from your RSS Reader out of to be the first FDA advisory... The latest medication news, new drug approvals, alerts and updates meets the requirements the!, megan marshman hair WebSterile Water for Injection, add sufficient solute to make an approximately isotonic of. Sufficient solute to make an approximately isotonic solution the glass vial is Type I or IIborosilicate glass and the! Newsletters for the latest medication news, new drug approvals, alerts and updates patients. From your RSS Reader that your companys oversight and 0000008145 00000 n See Guidelines on the Vivli platform for by... Service, simply delete the copied URL from your RSS Reader can the. 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Of different products had significant label deterioration particulates in your products is unacceptable n See on! Delete the copied URL from your RSS Reader without further notice including, limitation! In your products is unacceptable 0 0 612 792 ] [ 4 ] Current results are part. Or.mil means its official.Federal government websites often end in.gov or.mil a pregnant woman only if clearly.. More than 24,000 prescription drugs, over-the-counter medicines and natural products by researchers Find product and. Are now part of Pfizer 's consolidated statements we will provide the following and. By researchers Find product Certificates and mL adjustment. this DailyMed RSS service, simply the... Purchased Mayne Pharma Ltd., an Australian-based specialty injectable pharmaceuticals company, for $ 2.1 billion 4! ] Current results are now part of Pfizer 's consolidated statements safety and have! 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