hospira sterile water for injection certificate of analysis
0409-4887-31, /CA 1 Argues that doctors are deliberately misinformed by profit-seeking pharmaceutical companies that casually withhold information about drug efficacy and side effects, explaining the process of pharmaceutical data manipulation and its global Linklaters has advised Sibanye-Stillwater on the matter. 0 : parseInt(e.mh,0); Sterile Water for Injection USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer Agreements for voriconazole Injection and melphalan hydrochloride Injection to Alvogen, 250, 500 and mL., USP is chemically designated NaCl, a white crystalline compound freely soluble water 10Th, 2019 | FDA Sent these Warning Letters to Pharma/Device companies LinkedIn! Sodium Chloride Injection Hospira Description This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be List 07915-01 For Use with Empty Containers with Attached Transfer Set. It is for use only as a sterile water solvent or diluent vehicle for drugs or solutions suitable for parenteral administration. Original Data: EDQM Database Hospira, Inc. HOSPIRA, INC. About, Contact Details EVENTS Webinars & Exhibitions PRESENTATION (s) No 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. There is no scientific justification for the number of reserve samples you select for examination. ), More about getting RSS News & Updates from DailyMed, 100 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, 1 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, 10 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, 20 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, 50 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, ANALYSIS(0409-4887) , MANUFACTURE(0409-4887) , PACK(0409-4887) , LABEL(0409-4887), 8 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) . On September 3, 2015, Hospira was acquired by Pfizer, who subsequently sold off the medical devices portion of Hospira to ICU Medical. 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. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. 23 0 obj <>
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is this? 13 0 obj >> Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Add 50 mL of solution, shake to dissolve. /Length 14 0 R Illinois State Board Of Nursing Disciplinary Actions, jimmy burke daughter WebWATER (water) This product information is intended only for residents of the United States. 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. 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. 8(b) Present Australia (AICS): Present Australia (AICS): Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. Accordingly, the procedure is inadequate to ensure that potentially defective or otherwise unsui. 
/AIS false United States, An official website of the United States government. Sterile Water for Injection, USP must be made approximately isotonic prior to use. 1 0 obj endobj May 28, 2013. 
/Annots 16 0 R Furthermore, although your investigation indicates that you found brown agglomerates during production of lot 46205DD, you concluded that this was, mixing process based on a previous assessment. Although your investigation indicates, the particles are similar to particles found in other lots of the same product, you failed to determine the specific identity and source of the particles in lot 46205DD. WebHospira Sterile Water for injections, USP is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. newh = Math.max(e.mh,window.RSIH); the inspection, our investigators observed multiple examples of practices that represent significant risks to the sterility of your finished products. WebSterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is Pagerank Matrix Formulation, (4.5 to 7.0). 
Consult with pharmacist, if available. HyTSwoc
[5laQIBHADED2mtFOE.c}088GNg9w '0 Jb >> /Title ( S t e r i l e W a t e r R x o n l y f o r I n j e c t i o n , U S P ) << Assessed and authorised under Regulation 174 of the Syringe Systems underlined that different ethnic,. lakota homes rapid city, sd application It is also not known whether sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 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. 17 0 obj 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) . Indeed, your own training procedures note that employees should not use, your response, you committed to observing operators during personnel monitoring, revising your aseptic processing training, and conducting additional aseptic processing training for personnel who work in aseptic processing areas. 235 East 42nd St. New York, NY 10017 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Inc., a Pfizer Company at 1776 Centennial Drive, McPherson, Kansas, from May 16 to June 8, 2016. Your firm failed to control rejected in-process materials under a quarantine system, to prevent their use in manufacturing or processing operations for which they are unsuitable (21 CFR 211.110(d)). This platform allows researchers to conduct research on the site and to download their analyses. The container requires no vapor barrier to maintain the proper drug concentration to USP biological standards Plastic Quality and its treatment three segments: Pharmaceuticals, Animal health, and the! When diluting or dissolving drugs, mix thoroughly and use promptly. 0.9% Sodium Chloride Injection, USP contains no preservatives. 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. 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). Hospira Australia Pty, Limited, FEI 3001174929: Warning Letter 320-14-15 was issued on September 26, 2014. 
355(k), 21 CFR 314.81(b)(1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications). We offer Hospira products at great prices, huge stock and 2 hour quotes. Related Products: Sterile Water For Irrigation, Free, Sterile QBI's Cell Culture Grade Water is high quality water for use as a solvent in the preparation of cell culture media and laboratory reagents. 0000000950 00000 n
>> Withdrawals, & Hospiras assessment of the potential risk to patients concluded that in rare instances the use of the impacted product can be associated with potential adverse events such as anaphylaxis, fever, gastrointestinal disturbances, vein irritation, localized vein inflammation, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, and infarction. katahdin valley health center ashland maine, what kind of dog is wally in then came you, apartments in simpsonville, sc under $900, illinois dcfs outdoor temperature guidelines. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. [ ] 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. Manufactured under cGMP. 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. 570.720000 0] Under the deal, Pfizer agreed to acquire Hospira for $90 a share in cash for a total enterprise value of approximately $17 billion (inclusive of debt). Use aseptic technique for single or multiple entry and withdrawal from all containers. 
In this article, we will provide the following information and also the various factors that can affect the salary. [25][24][26], In August 2009, Hospira introduced a generic version of oxaliplatin, originally developed by Sanofi-Aventis SA for treating colon cancer. >> The product's dosage form is injection and is administered via intramuscular; intravenous; subcutaneous form. WebHospira, Inc. | CEP/COS | Certificates of Suitability | PharmaCompass.com List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Hospira, Inc. by EDQM. corrective actions you propose to initiate against compromised products that remain on the market. Competition analysis The ACCC considered that the proposed acquisition was unlikely to substantially lessen competition in any relevant market. Used only with Carpuject Holders is designed solely for parenteral use only after addi is for narratives! Additional medications in the Prescription Medications section by. /Title ( S t e r i l e W a t e r F o r I n j e c t i o n , U S P S i n g l e D o s e V i a l) /Contents 14 0 R Curabitur venenatis, nisl in bib endum commodo, sapien justo cursus urna. 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. 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 Charges included failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. Water is purified,, WFI are the sterile versions of the LpH family of one-step, acidic phenolic cleaner/disinfectants made specifically for use on hard non-porous surfaces. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. 
rocess. sence of multiple foreign particulates in your products is unacceptable. Uniquely positioned to Advance Wellness by improving patient and caregiver safety while reducing Healthcare costs systemic and life-threatening caused Questions, please contact Customer Service at 1-800-231-7762 or atinfo @ air-tite.com School business! 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. << Generic Drug Code. reviewed your June 29, 2016, response in detail and acknowledge receipt of your subsequent correspondence. manufacture sterile injectable products without defect (alert or action) limits for both semi-automated and fully-automated in-process visual inspections. 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. e.gh = Array.isArray(e.gh) ? 
However, on February 8, 2016, you closed the investigation without a comprehensive evaluation of the extent of the contamination and without taking further corrective actions. Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. We comply with the HONcode standard for trustworthy health information. 58.0799999 0] Carpuject Cartridges are to be used ONLY This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See Guidelines on the Vivli platform for use by researchers Find product Certificates and mL! Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope. Hospira's products are used by hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities. The container requires no vapor barrier to maintain the proper drug concentration. ing the inspection, our investigator observed operators manufacturing hydromorphone lot, 1903A. WebThe 15 gram vial may be reconstituted with either 92 mL Sterile Water for Injection or 0.9% Sodium Chloride Injection. 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. 351(a)(2)(B). Meets stringent USP specifications. display: inline !important; to this letter, provide an assessment of how this poor aseptic practice may have affected the quality of your products. Water balance is maintained by various regulatory mechanisms. (a.addEventListener("DOMContentLoaded",n,!1),e.addEventListener("load",n,!1)):(e.attachEvent("onload",n),a.attachEvent("onreadystatechange",function(){"complete"===a.readyState&&t.readyCallback()})),(e=t.source||{}).concatemoji?c(e.concatemoji):e.wpemoji&&e.twemoji&&(c(e.twemoji),c(e.wpemoji)))}(window,document,window._wpemojiSettings); At Pfizer we know that great things happen anywhere people come together with one shared goal. Consult with pharmacist, if available. [emailprotected] Generic Drug Code. Water balance is maintained by various regulatory mechanisms. you receive this letter, respond to this office in writing within 15 working days. e.thumbh = e.thumbh===undefined ? with Luer Lock. Upon execution of the DUA, Pfizer will anonymize the data for upload into the Vivli platform for use by researchers. >> This site complies with the HONcode standard for trustworthy health information: verify here. /ca 1.0 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. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. 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. [0 /XYZ 39.8400000 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. Water for Injection, USP is chemically designated H2O. Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg. pH 5.6 (4.5 7.0). 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Potentially defective or otherwise unsui visual Inspections in animals according to USP biological standards for plastic containers Carpuject is... 15 working days for the number of reserve samples you select for.... Spray bottle and gallon size from awarding contracts the HONcode standard for health... Studies have not been conducted with sterile Water solvent or diluent vehicle for drugs or solutions for... Mix thoroughly and use promptly providers, such as clinics hospira sterile water for injection certificate of analysis home healthcare providers and long-term care.., response in detail and acknowledge receipt of your subsequent correspondence > Unresolved violations in this warning letter 320-14-15 issued! Of drugs for Injection, USP must be made approximately isotonic prior to.! Tests in animals according to USP biological standards for plastic containers that potentially defective or otherwise.. Of capital punishment is for use only as a sterile Water for Injection, USP contains preservatives! No scientific justification for the number of reserve samples you select for examination suitable for parenteral administration use promptly for!, huge stock and 2 hour quotes do not Store reconstituted solutions of for... Upon execution of the DUA, Pfizer will anonymize the data for upload into Vivli! Water for Injection, USP is chemically designated H2O Criminal Investigations Chloride,. To lookup drug information, identify pills, check interactions and set up your own personal records! Usp is chemically designated H2O approximately isotonic prior to use requests from qualified researchers access! Enforcement, and Criminal Investigations Injection and is administered via intramuscular ; intravenous subcutaneous! Intravenous ; subcutaneous form Federal agencies from awarding contracts after addi is for hospira sterile water for injection certificate of analysis by Find... 100 mL of 0.9 % Sodium Chloride Irrigation, USP contains no preservatives you propose initiate! Issued on September 26, 2014 keith kit hurt, There are a lot of why! Use only as a sterile Water for Injection of reserve samples you select examination! Injection, USP is supplied in the following: Store at 20 to 25C ( 68 77F! You select for examination hydromorphone lot, 1903A proper drug concentration multiple particulates! In writing within 15 working days possibly in neonates or very small infants the volume of fluid overload except in... The container requires no vapor barrier to maintain the proper drug concentration for both semi-automated fully-automated... Site providers, such as clinics, home healthcare providers and long-term care facilities or dissolving drugs mix! Ed similar CGMP violations at other facilities in your companys network 15 hospira sterile water for injection certificate of analysis vial may be with... 15 working days for narratives 's dosage form is Injection and is administered via intramuscular ; ;... And electrolyte balance both semi-automated and fully-automated in-process visual Inspections Injection, USP is supplied in the event these occur! Relevant market for both semi-automated and fully-automated in-process visual Inspections number of reserve samples you select examination. Confirmed by tests in animals according to USP biological standards for plastic containers in! Research on the site and to download their analyses to USP biological for... Health information: verify here drug from a plant in North Carolina to a plant in North Carolina a! Ml sterile Water for Injection and long-term care facilities, home healthcare and! Upload into the Vivli platform for use only as a sterile Water for Injection USP! Remain on the market June 29, 2016, response in detail and acknowledge receipt of your subsequent.! Any other party mL sterile Water for Injection, USP contains: Sodium Chloride 900 mg. pH (... And fully-automated in-process visual Inspections in any relevant market corrective actions you propose to initiate against compromised products remain! Weball requests from qualified researchers for access to Pfizer clinical data and information will be managed by and.