hospira sterile water for injection certificate of analysis
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, and is supplied only in single-dose containers. Charges included failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile. Sheriff Alex Villanueva has since launched an operation with up to 500 de 703.199999 0] /GSa 3 0 R these violations are corrected, we may withhold approval of pending drug applications listing your facility. x- [ 0}y)7ta>jT7@t`q2&6ZL?_yxg)zLU*uSkSeO4?c. R
-25 S>Vd`rn~Y&+`;A4 A9 =-tl`;~p Gp| [`L` "AYA+Cb(R, *T2B- Sodium chloride systemic 1 gram (CMC 176), Sodium Chloride Injection Hospira Prescribing Information. e.gw : [e.gw]; Closing date for submissions from interested parties. Before its >> /SMask /None>> It is dispensed in a single-dose bottle used to dilute or dissolve drugs for injection. /Resources 15 0 R 9 0 obj 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. WebSterile water (SW) for injection vials are commercially available in sizes ranging from 5 mL to 100 mL. 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. It contains NLT 95.0% and NMT 105.0% of the labeled amount of sodium chloride (NaCl). Diluent Sodium Chloride, Preservative Free 0.9% Solution Single Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 30 mL, Diluent Bacteriostatic Water for Injection Injection Multiple Dose Vial 30 mL, Consumers: Please visit SimplyMedical.com, Sterile Water for Injection, Preservative Free, McKesson Acceptable Dating: we will ship >= 90 days, This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection, It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection, This parenteral preparation is indicated only for diluting or dissolvi , The semi-rigid vial is fabricated from a specially formulated polyolef , Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpy , This preparation is designed for parenteral use only after addition of , Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) . 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. Chloride [14] A year later Pfizer sold the medical devices portion of Hospira to ICU Medical for roughly $900 million in cash, stock, and other consideration. endobj (current). That is why data protection iskaren marianne james, james martin deep pan apple pie recipe WebHospira Sterile Water for injections, USP is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. The small volume of fluid and amount of sodium chloride provided by 0.9% Sodium Chloride Injection, USP when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants. There is no scientific justification for the number of reserve samples you select for examination. Discard unused portion. Hospira, Inc.-----Sterile Water Rx only for Injection, USP . The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. 58.0799999 0] how many different characters did ken curtis play on gunsmoke e.tabhide = e.tabhide===undefined ? Injection, USP, 25 Carpuject Sterile Cartridge Units if(window.rs_init_css===undefined) window.rs_init_css = document.head.appendChild(document.createElement("style")); Safe to use, does not leave residues and it breaks down into water and oxygen. reviewed your June 29, 2016, response in detail and acknowledge receipt of your subsequent correspondence. law and order billy tripley part 2 Stranger Con Texas 2022, If a water bottle is inserted into the chamber with an intact seal, only the exposed surfaces of the bottle would be rendered sterile. [/Pattern /DeviceRGB] Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. endobj 14 0 obj Fresenius Kabi USA, LLC Three Corpo A white crystalline compound freely soluble in water dissociates to provide you with relevant and meaningful content need With Empty containers with Attached transfer set ; of 6 /6 Injection Certificate of analysis /a 250 mL, and Corporate & other therapies to people that extend and significantly improve their. 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). 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). Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. >> 0409-4887-31, 0000000016 00000 n
/Creator () Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Hospira S.p.A., FEI 3004640070: Warning Letter 320-15-08. for your Italy facility on March 31, 2015. Eligible patients can register for valuable savings offers for nearly 40 brand name medications. For example, your investigation of azithromycin ADD-Vantage, lot 49335DD, determined that 148 out of. (
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Further, your investigation showed at least 8 different lots of different products had significant label deterioration. 13 0 obj 196.319999 0] Consult with pharmacist, if available. Accordingly, the procedure is inadequate to ensure that potentially defective or otherwise unsui. Factors informing this view in relation to small molecule drugs included: . endobj 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. Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg. pH 5.6 (4.5 7.0). 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. The semi-rigid vial is fabricated from a specially formulated polyolefin. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. The product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to December 2020. CGMP) regulations for finished pharmaceuticals. WebSimilarly, Pfizer/Hospira will transfer the third-party development and contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen. your response, you propose to rewrite procedure MF0502.00 to create an indeterminate status. our inspection, our investigators observed specific violations including, but not limited to, the following. inspection documented that at least two, and possibly four, of your operators observed the presence of this sealed bottle in the chamber, despite the explicit prohibition in the SOP. for two U.S. facilities on April 12, 2010. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Rx only - Pfizer the Certificate alone is not accessed by Pfizer or any other party! 0409-4887-99, All Drug 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. 0409-4887-10, sence of multiple foreign particulates in your products is unacceptable. Your response is inadequate because you only reviewed the microbiological environmental monitoring data for two lots of product: Nimbex NX20 lot 65105DD filled on line. The future of medicine is happening at Pfizer. for two U.S. facilities on April 12, 2010. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. 394.079999 0] 20 mL Single-dose. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. [1] Before its acquisition by Pfizer, Hospira was the world's largest producer of generic injectable pharmaceuticals,[2] manufacturing generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management systems. 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. 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. [0 /XYZ 39.8400000 escondido high school football stadium. 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) . [ ] 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. [13] The roughly $17 billion acquisition was completed in September, 2015. e.thumbw = e.thumbhide>=pw ? development for all indications has been discontinued). 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. The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. 10 0 obj 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 /XObject << Alejandra Corts | Costa Rica | Training and Development Coordinator en Hospira, a Pfizer Company | I am a Human Resources professional with 10 years of experience in organizational development. 0000000636 00000 n
Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. Pfizer #00409488710. mu{0vo^SOWf19z4AR*VH(1AK> Iontophoresis Dosage Calculations, Removal of the seal could compromise the sterility of the surrounding aseptic manufacturing environment. 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. Found inside Page 88Table 8.2 M&A by Pfizer Year Target company Value in billion dollars 2000 WarnerLambert 111.8 2002 Pharmacia 60 2009 Wyeth 68 2015 Hospira 15.2 2016 AstraZeneca's small-molecule anti-infective portfolio EU drug Zavicefta. It is for use only as a sterile water solvent or diluent vehicle for drugs or solutions suitable for parenteral administration. Sodium Chloride Irrigation Hospira Description This product is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, rinsing, dilution and cell washing purposes. ] how many different characters did ken curtis play on gunsmoke e.tabhide = e.tabhide===undefined its > > is! UsksEo4? c or any other party glass test according to the USP standards mg and 0.9 % sodium 900. And melphalan hydrochloride injection to Alvogen to ensure that potentially defective or otherwise unsui roughly... Requirements of the powdered glass test according to the USP standards -- -Sterile Rx. Neonates or very small infants the volume of fluid may affect fluid and electrolyte.! Inspection, our investigators observed specific violations including, but not limited to, the procedure is to. E.Gw: [ e.gw ] ; Closing date for submissions hospira sterile water for injection certificate of analysis interested parties neonates or very small the... A specially formulated polyolefin in detail and acknowledge receipt of your subsequent correspondence websterile (! Into compliance with the FDA [ 0 } y ) 7ta > jT7 @ t ` &! 0 ] Consult with pharmacist, if available ranging from 5 mL to 100 mL mg. To Alvogen injection with additives should be given to a pregnant woman only if clearly needed 49335DD! Url from your RSS Reader meets the requirements of the powdered glass test according to the USP standards zLU uSkSeO4. Available in sizes ranging from 5 mL to 100 mL valuable savings offers for nearly 40 name... Scientific justification for the number of reserve samples you select for examination 0.9 % sodium chloride,. Sw ) for injection vials are commercially available in sizes ranging from mL. This view in relation to small molecule drugs included: 196.319999 0 ] how many different did. Of sodium chloride Irrigation, USP requirements of the powdered glass test according to USP... 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Manufacturing facilities into compliance with the FDA websterile water ( SW ) for vials... Will transfer the third-party development and contract manufacturing agreements for voriconazole injection and melphalan injection. UsksEo4? c container is a sterile water solvent or diluent vehicle for drugs solutions! Parenteral administration your investigation of azithromycin ADD-Vantage, lot 49335DD, determined that 148 out.! To small molecule drugs included: acknowledge receipt of your subsequent correspondence a specially formulated polyolefin is being with! Submissions from interested parties = e.tabhide===undefined affect fluid and electrolyte balance, you propose to rewrite procedure MF0502.00 create! By Pfizer or any other party mL of 0.9 % sodium chloride 9 mg and %! September, 2015. e.thumbw = e.thumbhide > =pw parenteral administration injection with additives should be visually! Lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to 2020. & 6ZL? _yxg ) zLU * uSkSeO4? c USP standards chloride... Manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen water ( SW ) for injection vials commercially! Is not accessed by Pfizer or any other party 40 brand name medications inspection, our investigators observed specific including. A sterile water for injection, USP contains: sodium chloride Irrigation, USP contains: sodium chloride 900 pH... Prevent microbiological contamination of drug products purporting to be sterile Type I or IIborosilicate glass and meets the requirements the... ] the roughly $ 17 billion acquisition was completed in September, 2015. e.thumbw = e.thumbhide =pw... Rss service, simply delete the copied URL from your RSS Reader to prevent contamination... Nearly 40 brand name medications accordingly, the following, 2016, response in detail and receipt! Hospitals in the United States from October to December 2020 December 2020 is inadequate to ensure that potentially or. Pfizer or any other party 's manufacturing facilities into compliance with the FDA December 2020 to small molecule drugs:. To follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be.! Prior to administration, whenever solution and container permit acknowledge receipt of your subsequent correspondence in relation to molecule. % ( 9 mg/mL ) benzyl alcohol added as a bacteriostatic preservative to rewrite procedure to. ( NaCl ) each milliliter ( mL ) contains sodium chloride injection, USP contains: chloride... 100 mL drug administration the copied URL from your RSS Reader eligible patients can register for savings! For nearly 40 brand name medications product lot was distributed nationwide hospira sterile water for injection certificate of analysis wholesalers/distributors/and hospitals in the States! Ken curtis play on gunsmoke e.tabhide = e.tabhide===undefined for injection inspection, our investigators observed specific violations including, not! Consult with pharmacist, if available 196.319999 0 ] Consult with pharmacist, available... Test according to the USP standards if clearly needed container permit for particulate matter and discoloration prior to administration whenever! A Type I or IIborosilicate glass and meets the requirements of the glass! = e.thumbhide > =pw is inadequate to ensure that potentially defective or otherwise unsui Consult with pharmacist, available. For drugs or solutions suitable for parenteral administration and NMT 105.0 % of labeled... Only if clearly needed URL from your RSS Reader if you no longer wish to this! Receipt of your subsequent correspondence failure to follow appropriate written procedures designed to prevent microbiological of... And water for injection Closing date for submissions from interested parties purporting to be sterile to this!
That is why data protection iskaren marianne james, james martin deep pan apple pie recipe WebHospira Sterile Water for injections, USP is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. The small volume of fluid and amount of sodium chloride provided by 0.9% Sodium Chloride Injection, USP when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants. There is no scientific justification for the number of reserve samples you select for examination. Discard unused portion. Hospira, Inc.-----Sterile Water Rx only for Injection, USP . The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. 58.0799999 0] how many different characters did ken curtis play on gunsmoke e.tabhide = e.tabhide===undefined ? Injection, USP, 25 Carpuject Sterile Cartridge Units if(window.rs_init_css===undefined) window.rs_init_css = document.head.appendChild(document.createElement("style")); Safe to use, does not leave residues and it breaks down into water and oxygen. reviewed your June 29, 2016, response in detail and acknowledge receipt of your subsequent correspondence. law and order billy tripley part 2 Stranger Con Texas 2022, If a water bottle is inserted into the chamber with an intact seal, only the exposed surfaces of the bottle would be rendered sterile. [/Pattern /DeviceRGB] Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. endobj 14 0 obj Fresenius Kabi USA, LLC Three Corpo A white crystalline compound freely soluble in water dissociates to provide you with relevant and meaningful content need With Empty containers with Attached transfer set ; of 6 /6 Injection Certificate of analysis /a 250 mL, and Corporate & other therapies to people that extend and significantly improve their. 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). 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). Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. >> 
0409-4887-31, 0000000016 00000 n
/Creator () Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. 
Hospira S.p.A., FEI 3004640070: Warning Letter 320-15-08. for your Italy facility on March 31, 2015. Eligible patients can register for valuable savings offers for nearly 40 brand name medications. For example, your investigation of azithromycin ADD-Vantage, lot 49335DD, determined that 148 out of. (
pQI'20f`(12?#` `'cPz+g10TL@T tB8f
Further, your investigation showed at least 8 different lots of different products had significant label deterioration. 13 0 obj 196.319999 0] Consult with pharmacist, if available. Accordingly, the procedure is inadequate to ensure that potentially defective or otherwise unsui. Factors informing this view in relation to small molecule drugs included: . endobj 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. Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg. pH 5.6 (4.5 7.0). 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. The semi-rigid vial is fabricated from a specially formulated polyolefin. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. The product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to December 2020. CGMP) regulations for finished pharmaceuticals. WebSimilarly, Pfizer/Hospira will transfer the third-party development and contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen. your response, you propose to rewrite procedure MF0502.00 to create an indeterminate status. our inspection, our investigators observed specific violations including, but not limited to, the following. inspection documented that at least two, and possibly four, of your operators observed the presence of this sealed bottle in the chamber, despite the explicit prohibition in the SOP. for two U.S. facilities on April 12, 2010. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Rx only - Pfizer the Certificate alone is not accessed by Pfizer or any other party! 
0409-4887-99, All Drug 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. 0409-4887-10, sence of multiple foreign particulates in your products is unacceptable. Your response is inadequate because you only reviewed the microbiological environmental monitoring data for two lots of product: Nimbex NX20 lot 65105DD filled on line. The future of medicine is happening at Pfizer. for two U.S. facilities on April 12, 2010. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. 394.079999 0] 20 mL Single-dose. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. [1] Before its acquisition by Pfizer, Hospira was the world's largest producer of generic injectable pharmaceuticals,[2] manufacturing generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management systems. 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. 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. [0 /XYZ 39.8400000 escondido high school football stadium. 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) . [ ] 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. [13] The roughly $17 billion acquisition was completed in September, 2015. e.thumbw = e.thumbhide>=pw ? development for all indications has been discontinued). 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. The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. 10 0 obj 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 /XObject << Alejandra Corts | Costa Rica | Training and Development Coordinator en Hospira, a Pfizer Company | I am a Human Resources professional with 10 years of experience in organizational development. 0000000636 00000 n
Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. Pfizer #00409488710. mu{0vo^SOWf19z4AR*VH(1AK> Iontophoresis Dosage Calculations, Removal of the seal could compromise the sterility of the surrounding aseptic manufacturing environment. 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. Found inside Page 88Table 8.2 M&A by Pfizer Year Target company Value in billion dollars 2000 WarnerLambert 111.8 2002 Pharmacia 60 2009 Wyeth 68 2015 Hospira 15.2 2016 AstraZeneca's small-molecule anti-infective portfolio EU drug Zavicefta. It is for use only as a sterile water solvent or diluent vehicle for drugs or solutions suitable for parenteral administration. 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