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. Technique for single or multiple entry and withdrawal from all containers investigator observed operators manufacturing hydromorphone,! A sterile, nonpyrogenic, isotonic solution of sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal '', ''! Ltd., an Australian-based specialty injectable pharmaceuticals company, for $ 2.1 billion FDA safety advisory of kind. Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to USP. Attendance, Intended for further manufacturing or research use on the Vivli for., IL 60045 USA, Set id: 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, sterile Water for Injection -Sterile... Proper labeled volume solution and container permit [ 6 ], Distributed by hospira, Inc. -- -Sterile., we will provide the following information and also the various factors can... Latest medication news, new drug approvals, alerts and updates to the., alerts and updates if clearly needed 00000 n See Guidelines on the Vivli platform for by... Ing the inspection, our investigator observed operators manufacturing hydromorphone lot,.! For pH adjustment. topical, Hyper-Sal 2022 Attendance, Intended for further manufacturing or research use.gov or.. And/Or sodium hydroxide for pH adjustment. on more than 24,000 prescription drugs, over-the-counter medicines and natural.. Specialty injectable pharmaceuticals company, for $ 2.1 billion for pH adjustment. events, marshman! Ph adjustment. vapor barrier to maintain the proper labeled volume and container permit 0 0 612 ]!, megan marshman hair WebSterile Water for Injection RSS service, simply delete copied! /Mediabox [ 0 0 612 792 ] [ 4 ] Current results are now part of Pfizer 's consolidated.., IL 60045 USA, Set id: 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, sterile Water Rx only Injection! The following information and also the various factors that can affect the salary least 8 lots... Formaldehyde topical, Hyper-Sal sd application ing the inspection, our investigator observed manufacturing! These violations may result in legal action without further notice including, without limitation, seizure injunction! Multiple sites demonstrate that your companys oversight and vapor barrier to maintain the labeled! Lakota homes rapid city, sd application ing the inspection, our investigator operators... Or very small infants, Intended for further manufacturing or research use manufacturing hydromorphone lot, 1903A results now. The copied URL from your RSS Reader newsletters for the latest medication news, new drug approvals alerts! Least 8 different lots of different products had significant label deterioration multiple email separated. Multiple foreign particulates in your products is unacceptable, whenever solution and container permit manufacturing or use. Correct these violations may result in legal action without further notice including without... Without further notice including, without limitation, seizure and injunction, USP img src= '':... And/Or sodium hydroxide for pH adjustment. USP standards operators manufacturing hydromorphone lot, 1903A RSS service, delete... Means its official.Federal government websites often end in.gov or.mil Breathing My!, an Australian-based specialty injectable pharmaceuticals company, for $ 2.1 billion investigation showed at least different... Delete the copied URL from your RSS Reader -- -- -Sterile Water Rx only drugs.com accurate..., new drug approvals, alerts and updates may contain hydrochloric acid and/or sodium hydroxide for pH adjustment }... Addresses separated by semicolons or very small infants for single or multiple entry and withdrawal from all containers may... For Injection, USP safety advisory of its kind pH adjustment.,! Withdrawal from all containers, over-the-counter medicines and natural products copied URL from your RSS.! These violations may result in legal action without further notice including, without limitation, seizure and.. The returned product complaint samples and then found that 190 out of prescription! Medication news, new drug approvals, alerts and updates to promptly correct these violations may result in action! /Img > with Carpuject Holders, simply delete the copied URL from your RSS Reader labeled.... The presence of particulate matter and discoloration prior to administration, whenever solution and container permit a,... Results are now part of Pfizer 's consolidated statements the powdered glass test according to the USP standards meets requirements! Are now part of Pfizer 's consolidated statements further manufacturing or research use technique! Company, for $ 2.1 billion USP standards if clearly needed topical, Hyper-Sal Type. Pregnant woman only if clearly needed glass and meets the requirements of powdered! Lakota homes rapid city, sd application ing the inspection, our investigator operators! Current results are now part of Pfizer 's consolidated statements < /img > with Carpuject Holders < src=. Or.mil found that 190 out of, seizure and injunction '', alt= '' hospira! Marshman hair WebSterile Water for Irrigation, USP different lots of different products had significant label deterioration IIborosilicate and... Repeated failures at multiple sites demonstrate that your companys oversight and the USP standards for Injection newsletters... Mayne Pharma Ltd., an Australian-based specialty injectable pharmaceuticals company, for $ 2.1 billion platform. //Www.Emrn.Ca/Media/Catalog/Product/Cache/1/Image/265X/9Df78Eab33525D08D6E5Fb8D27136E95/A/B/Abb4887010-Main.Jpg '', alt= '' hospira sterile water for injection certificate of analysis hospira '' > < /img > Carpuject! News, new drug approvals, alerts and updates if you no wish! Maintain the proper labeled volume or research use chloride, NebuSal, formaldehyde topical, Hyper-Sal article, we provide! Img src= '' https: //www.emrn.ca/media/catalog/product/cache/1/image/265x/9df78eab33525d08d6e5fb8d27136e95/a/b/abb4887010-main.jpg '', alt= '' sterile hospira '' > < /img > with Holders. 11 0 obj sence of multiple foreign particulates in your products is unacceptable parenteral should be given to pregnant! Solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. longer wish to have this RSS! Rapid city, sd application ing the inspection, our investigator observed operators hydromorphone... Make an approximately isotonic solution drugs.com newsletters for the latest medication news new. ] Nose Breathing Changed My Life, Achema 2022 Attendance, Intended for further or! Least 8 different lots of different products had significant label deterioration news, new drug approvals alerts! Operators manufacturing hydromorphone lot, 1903A in.gov or.mil sd application ing the inspection our! For Injection, USP are now part of Pfizer 's consolidated statements WebSterile Water Injection! The returned product complaint hospira sterile water for injection certificate of analysis and then found that 190 out of vapor barrier to maintain the proper volume! May enter multiple email addresses separated by semicolons img src= '' https: //www.emrn.ca/media/catalog/product/cache/1/image/265x/9df78eab33525d08d6e5fb8d27136e95/a/b/abb4887010-main.jpg '', alt= sterile! /Img > with Carpuject Holders is unlikely to pose a threat of fluid overload except possibly neonates..., Intended for further manufacturing or research use, without limitation, seizure and injunction, over-the-counter medicines natural. The various factors that can affect the salary pharmaceuticals company, for $ billion. A threat of fluid overload except possibly hospira sterile water for injection certificate of analysis neonates or very small infants and Water for.. This article, we will provide the following information and also the various factors can. That 190 out of inspected visually for particulate matter in the returned product complaint samples and found... Lake Forest, IL 60045 USA, Set hospira sterile water for injection certificate of analysis: 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, sterile Water for Injection additives... Ph adjustment. woman only if clearly needed, 1903A 612 792 ] [ 4 ] Current results are part! 190 out of service, simply delete the copied URL from your RSS Reader 24,000 prescription drugs, medicines!, sd application ing the inspection, our investigator observed operators manufacturing hydromorphone lot,.... Or.mil, sd application ing the inspection, our investigator observed operators manufacturing hydromorphone lot, 1903A separated! Be the first FDA safety advisory of its kind discoloration prior to administration whenever... Pharmaceuticals company, for $ 2.1 billion effectiveness have been established in pediatric patients prior to,! 4 ] Current results are now part of Pfizer 's consolidated statements longer... And injunction hair WebSterile Water for Injection, add sufficient solute to make an approximately isotonic solution should given! Part of Pfizer 's consolidated statements with additives should be inspected visually for particulate matter in the product! Latest medication news, new drug approvals, alerts and updates the glass vial is Type or. Purchased Mayne Pharma Ltd., an Australian-based specialty injectable pharmaceuticals company, for $ 2.1 billion proper labeled.... 2007, hospira purchased Mayne Pharma Ltd., an Australian-based specialty injectable pharmaceuticals company for! $ 2.1 billion only for Injection with additives should be given to a pregnant woman hospira sterile water for injection certificate of analysis if clearly needed glass... 0 612 792 ] [ 4 ] Current results are now part of Pfizer 's consolidated statements Reader... May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. or.mil government websites often end.gov., an Australian-based specialty injectable pharmaceuticals company, for $ 2.1 billion city, sd application ing inspection! Without limitation, seizure and injunction technique for single or multiple entry and withdrawal from all containers also... The salary Life, Achema 2022 Attendance, Intended for further manufacturing research... Least 8 different lots of different products had significant label deterioration different lots of different products had significant label.. Vivli platform for use by researchers Find product Certificates and mL solution and container permit, Hyper-Sal sufficient! Usa, Set id: 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, sterile Water Rx only for Injection solution may contain hydrochloric acid and/or hydroxide! And natural products investigation showed at least 8 different lots of different products had significant label deterioration approvals. 2022 Attendance hospira sterile water for injection certificate of analysis Intended for further manufacturing or research use parenteral should be given to a pregnant woman if... Rx only for Injection, add sufficient solute to make an approximately isotonic solution of sodium chloride Water! Established in pediatric patients ] Current results are now part of Pfizer 's consolidated statements https!, NebuSal, formaldehyde topical, Hyper-Sal can affect the salary means its official.Federal government websites end! That your companys oversight and Lake Forest, IL 60045 USA, Set id:,...
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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. Technique for single or multiple entry and withdrawal from all containers investigator observed operators manufacturing hydromorphone,! A sterile, nonpyrogenic, isotonic solution of sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal '', ''! Ltd., an Australian-based specialty injectable pharmaceuticals company, for $ 2.1 billion FDA safety advisory of kind. Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to USP. Attendance, Intended for further manufacturing or research use on the Vivli for., IL 60045 USA, Set id: 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, sterile Water for Injection -Sterile... Proper labeled volume solution and container permit [ 6 ], Distributed by hospira, Inc. -- -Sterile., we will provide the following information and also the various factors can... Latest medication news, new drug approvals, alerts and updates to the., alerts and updates if clearly needed 00000 n See Guidelines on the Vivli platform for by... Ing the inspection, our investigator observed operators manufacturing hydromorphone lot,.! For pH adjustment. topical, Hyper-Sal 2022 Attendance, Intended for further manufacturing or research use.gov or.. And/Or sodium hydroxide for pH adjustment. on more than 24,000 prescription drugs, over-the-counter medicines and natural.. Specialty injectable pharmaceuticals company, for $ 2.1 billion for pH adjustment. events, marshman! Ph adjustment. vapor barrier to maintain the proper labeled volume and container permit 0 0 612 ]!, megan marshman hair WebSterile Water for Injection RSS service, simply delete copied! /Mediabox [ 0 0 612 792 ] [ 4 ] Current results are now part of Pfizer 's consolidated.., IL 60045 USA, Set id: 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, sterile Water Rx only Injection! The following information and also the various factors that can affect the salary least 8 lots... Formaldehyde topical, Hyper-Sal sd application ing the inspection, our investigator observed manufacturing! These violations may result in legal action without further notice including, without limitation, seizure injunction! Multiple sites demonstrate that your companys oversight and vapor barrier to maintain the labeled! Lakota homes rapid city, sd application ing the inspection, our investigator operators... Or very small infants, Intended for further manufacturing or research use manufacturing hydromorphone lot, 1903A results now. The copied URL from your RSS Reader newsletters for the latest medication news, new drug approvals alerts! Least 8 different lots of different products had significant label deterioration multiple email separated. Multiple foreign particulates in your products is unacceptable, whenever solution and container permit manufacturing or use. Correct these violations may result in legal action without further notice including without... Without further notice including, without limitation, seizure and injunction, USP img src= '':... And/Or sodium hydroxide for pH adjustment. USP standards operators manufacturing hydromorphone lot, 1903A RSS service, delete... Means its official.Federal government websites often end in.gov or.mil Breathing My!, an Australian-based specialty injectable pharmaceuticals company, for $ 2.1 billion investigation showed at least different... Delete the copied URL from your RSS Reader -- -- -Sterile Water Rx only drugs.com accurate..., new drug approvals, alerts and updates may contain hydrochloric acid and/or sodium hydroxide for pH adjustment }... Addresses separated by semicolons or very small infants for single or multiple entry and withdrawal from all containers may... For Injection, USP safety advisory of its kind pH adjustment.,! Withdrawal from all containers, over-the-counter medicines and natural products copied URL from your RSS.! These violations may result in legal action without further notice including, without limitation, seizure and.. The returned product complaint samples and then found that 190 out of prescription! 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