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) . e.tabw = e.tabhide>=pw ? 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. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. .wp-block-pullquote{font-size: 1.5em;line-height: 1.6;} Keto Grocery Singapore, Keto Grocery Singapore, e.thumbh = e.thumbh===undefined ? .no-flex{display:block}.sub-header{margin-bottom:1em} document.getElementById(e.c).height = newh+"px"; The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. 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. manufacture sterile injectable products without defect (alert or action) limits for both semi-automated and fully-automated in-process visual inspections. 351(a)(2)(B). Labels, All Index Made according to USP specifications and packaged in a Class 100, Ideal for transformation, transfection, oocyte injection and all other research applications. Warning letters posted this week include ones demonstrating FDAs continued focus on over-the-counter (OTC) product manufacturers and manufacturers in India, including a particularly testy letter to Pfizer for a Hospira site in India that they are closing. if ( ! Shop risk-free with our 30 day return policy. Soliton Technologies Lahore, Hospira is voluntarily recalling one lot of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a report Available in many sizes to meet your needs, QBI's Cell Culture Grade Water for Cell Culture features: Water For Injection , Related Products: Cell Culture Grade Water, spectrum of common bacteria and fungi. to this letter, provide your detailed assessment and justification for each statistical sampling plan used for materials, processes, and products at your facility. Hospira, Inc.-----Sterile Water Rx only for Injection, USP . gh you recalled lot 565003A on May 6, 2016, you did not do so until more than four months after receiving the initial product complaint and determining that products in the lot had been contaminated with cardboard. 420 Throckmorton Street, Suite 200, Fort Worth Texas 76102, Copyright 2022 BacteriostaticWater.com - All Rights Reserved, Wholesale Hospira Bacteriostatic Water for Injection Supplier, Need help? 2B0306. Starbucks Reserve Nyc, It is a copolymer of ethylene and propylene. Sterile Water for Injection USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer Soliton Technologies Lahore, Discard unused portion. Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. e.tabh = e.tabh===undefined ? If you are a consumer or patient please visit Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. Artificial cerebrospinal fluid (aCSF) is commonly used to maintain the oxygen supply, osmolarity and buffer pH of isolated neurons and brain slices in electrophysiology experiments. 0 : e.tabh; This procedure does not require operators to quarantine initially rejected, for later reinspection, account for the number of units that are subjected to reinspection, or document the difference between the initial inspection results and reinspection results. Found inside Page 1028SUMMARY Fig. This webcast may contain forward-looking statements about, among other things, our anticipated operating and financial performance, reorganizations, 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, clinical trial results and other developing data that become available, revenue contribution, growth, performance, timing of exclusivity and potential benefits; strategic reviews; capital allocation objectives; dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, and our ability to successfully capitalize on these opportunities; manufacturing and product supply; our efforts to respond to COVID-19, including the Pfizer-BioNTech COVID-19 vaccine and our investigational protease inhibitor; and our expectations regarding the impact of COVID-19 on our business that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. var root = document.getElementsByTagName( 'html' )[ 0 ] Lot-specific certificate of analysis (CoA) for each lot of water produced. ), genetic data and exploratory biomarker data. WebHospira, Inc. | CEP/COS | Details of Certificates of Suitability | Pharmacompass.com List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Hospira, Inc. by EDQM. sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal. 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. Get Label RSS Feed, xecutive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. [0 /XYZ 69.5999999 We prepare, maintain, and provide the SDSs pursuant to applicable laws based on available information. Anticipated future financial performance that involve substantial risks and uncertainties used for products manufactured TSK. 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) . Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Our investigator noted many complaints related to particulate matter in sterile injectable products manufactured at your facility, indicating that the lack of defect limits for visual inspections may have resulted in the release of products that otherwise would not have been distributed. Stranger Con Texas 2022, Hospira, Inc.-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use 6% Hetastarch in 0.9% Sodium Chloride Injection safely and effectively. Web10ml Sterile Water (priced per bottle) Hospira Sterile Water for injections, USP is a sterile, non-pyrogenic preparation of water for injection that contains no bacteriostat, Similarly, Pfizer/Hospira will transfer the third-party development and contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen. 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. Get pharmaceutical product and services; of 6 /6. Commission ( EC ) in August Empty containers with Attached transfer set and services ; of /6. This site complies with the HONcode standard for trustworthy health information: verify here. 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. WebDESCRIPTION. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. !, discard unused portion and vaccines as well as many of the electronic Certificate of analysis /a On available information need to take any action regarding their shares until contacted by the George Washington University School business. '' Diluent Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL. Soluble ) and freedom from unexpected precipitation or discoloration prior to administration is a copolymer of ethylene and.! Certificate of analysis ( CoA ) for each lot of Water produced for trustworthy information! 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