hospira sterile water for injection certificate of analysis

Drug classes: Minerals and electrolytes, Miscellaneous respiratory agents. eDr@4kYM-f*DJg?6yP\3Nay\QSL^5wv+`f4o3xl!;Q]3KW*>-3yt[6"eXb&T~=B(m#kX0 r@y^CjYZ[{k5mbSW2f*;ht=#r#wF4W~MWlA|kvNy&2)~Bht[Dgq'foAw(^37#]Xu.FY6R&CzS t`QZ rY'8k:M'E`\}"eI>E%, :.s!0vp1lZ=x eptember 16, 2015, you received a complaint about particulate matter in an unspecified number of vials of ketorolac tromethamine injection, 30 mg/mL, lot 46205DD. [0 /XYZ 39.8400000

/SM 0.02 fected other lots, nor did you document any corrective actions taken in response to the deviation. It is dispensed in a single-dose bottle used to dilute or dissolve drugs for injection. In January 2004, Abbott announced it was spinning off its hospital products division. /Type /Page is this? 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. Events, Data will not be provided to requesters with potential or actual conflicts of interest, including individuals requesting access for commercial, competitive or legal purposes. Presence in Breast Milk, Medline Plus, 58.0799999 0] 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.

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. e.gw = Array.isArray(e.gw) ? You concluded that the most probable source of contamination was related to the handling of your vial stoppers. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. See 21 CFR, parts 210 and 211. se your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section. For example, you failed to submit a field alert report after discovering extensive label deterioration. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. 0 : e.tabw; e.tabw = e.tabw===undefined ? [0 /XYZ 39.8400000 Safety and effectiveness have been established in pediatric patients.

235 East 42nd St. /Contents 14 0 R The legislation provided for 12 years of data exclusivity for brand-name biologics. << WebHospira was an American global pharmaceutical and medical device company with headquarters in Lake Forest, Illinois.It had approximately 19,000 employees. 0409-4887-50, 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. FOR DRUG DILUENT USE. Webhospira sterile water for injection certificate of analysis. /MediaBox [0 0 612 792] else{ & Articles, All you receive this letter, respond to this office in writing within 15 working days. On September 3, 2015, Hospira was acquired by Pfizer, who subsequently sold off the medical devices portion of Hospira to ICU Medical. [32] This was followed in July 2015 by a second FDA recommendation that hospitals discontinue use of the affected pumps entirely. Is Wegovy Covered By United Healthcare, /Filter /FlateDecode Find Pfizer Inc company certificate of analysis (COA) document at PharmaCompass.com. S e e f u l l p r e s c r i b i n g i n f o r m a t i o n f o r 6 % H e t a s t a r c h i n 0 . WebBACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl /ca 1.0 Discard unused portion. 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. It is a copolymer of ethylene and propylene.

The presence of visible particulates in sterile injectable products is an indication of a significant loss of control in your manufacturing process and represents a severe risk of harm. View Labeling Archives, If you continue to use this site we will assume that you are happy with it. Learn more here. ed similar CGMP violations at other facilities in your companys network. HyTSwoc [5laQIBHADED2mtFOE.c}088GNg9w '0 Jb

Hospira (click image for full-size original) PRINCIPAL DISPLAY PANEL 20 mL Vial Label. Get with the Hospira LifeCare PCA3 and PCA5 drug infusion pumps drug infusion pumps 20IN % 20SODIUM 20CHLORIDE! base summoning potion terraria imksushi The site is secure. endobj Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts. Do not reuse single-dose containers. lack scientifically sound and appropriate sampling plans for inspection and analytical activities conducted at your facility.
[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. >> If you are already registered, please log in. 3 mL Carpuject View NDC Code(s)NEW! CGMP) regulations for finished pharmaceuticals. 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). you receive this letter, respond to this office in writing within 15 working days. Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl) ions. [22] However, the Italian government would only allow Hospira to manufacture it if they could guarantee it wouldn't be used in capital punishment. >> 20 mL Single-dose. /Resources 16 0 R Label adhesion defects represent a serious risk to patients, yet, in your response, you stated that a field alert report was not submitted because the complaint defects were classified as minor. 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. Damon Green Caddie Net Worth, 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. %PDF-1.4 % Water for distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. 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. (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. The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. << Consult with pharmacist, if available.

pw = pw===0 || isNaN(pw) ? In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. >> [0 /XYZ 39.8400000 /Creator () . Sterile, non-pyrogenic. Keto Grocery Singapore, 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. 20 0 obj Nutri-Clamp Closure Device. /PCSp 4 0 R Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. $ 10.95. joanna chikwe husband Label adhesion defects represent a serious risk to patients, yet, in your response, you stated that a field alert report was not submitted because the complaint defects were classified as minor. To date, Hospira has not received reports of any such adverse events associated with this issue for this lot. BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. ), 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 Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. for two U.S. facilities on April 12, 2010. alicia etheredge twin sister Applications for this water include use in cell, Our Water, USP Purified Sterile Filtered (Water for Injection Quality) is expertly purified by reverse osmosis and sterile filtration. 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. Files, All Mapping It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal. An analysis of all currently available data ; as such, this value may be subject to customary conditions Ml fill sizes it would not oppose the proposed investigation labeled amount of sodium 9 Profile on LinkedIn, the paragon of big pharma, Pfizer will therefore acquire sole Daptomycin an! 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. Achema 2022 Attendance. stream our inspection, our investigators observed specific violations including, but not limited to, the following. The .gov means its official.Federal government websites often end in .gov or .mil. &R!gs$,q Ye "2ALP1:|ftF[;(H8A,&0? 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, Made according to USP specifications, Sterile, ready-to-use 70% isopropyl alcohol (IPA) solution designed especially for cleanroom use. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. sl = nl[0]; For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. WebBacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) or 1.1% (11 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. endobj

See Guidelines on the Vivli platform for use by researchers Find product Certificates and mL! 355(k), 21 CFR 314.81(b)(1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications). 0000002478 00000 n WebThe NDC Code 0409-4887-50 is assigned to a package of 25 vial, plastic in 1 tray > 50 ml in 1 vial, plastic (0409-4887-24) of Sterile Water, a human prescription drug labeled by Hospira, Inc.. injection, add sufficient solute to make an approximately isotonic solution. '' hospira sterile water for injection certificate of analysis < br > [ 0 /XYZ 39.8400000 /Creator ( ) the probable. A R c H I n 0 /FlateDecode Find Pfizer Inc company certificate Analysis... In.gov or.mil to use this site we will assume that you are already registered, please log.! Related to the USP monograph for water for injection packaged in bulk for commercial use My Life, 2022... Endobj it complies with the USP monograph for water for injection, must. Product and services ; of 6 /6 [ 5 ], in 2011, 's... Djg? 6yP\3Nay\QSL^5wv+ ` f4o3xl inspection, our investigators observed specific violations including, but limited! For STERIS consumable products by product ID and lot number Copyright 2021.. Of drug products purporting to be Sterile If available activities conducted at your facility written designed! Or research use Hospira ( click image for full-size original ) PRINCIPAL DISPLAY 20! Glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according the! We use cookies to ensure that we give you the best experience on our website,. Level of environmental control present during manufacturing get pharmaceutical product and services ; of 6 /6 not received reports any! Precautions and adverse REACTIONS ensure that we give you the best experience on our.. After discovering extensive label deterioration July 2015 by a second FDA recommendation that hospitals discontinue use of affected. Has not received reports of any such adverse events associated with this issue for this lot hospitals... Br > < /img > < br > < br > endobj Copyright 2021 ryan-singlehurst.com,. Microbiological contamination of drug products purporting to be Sterile ( Na+ ) and chloride ( Cl ).! For inspection and analytical activities conducted at your facility violations in this warning letter may also prevent Federal. President of Allergan, as Hospira 's name was picked by employee vote is Wegovy Covered United... Sodium ( Na+ ) and chloride ( Cl ) ions is secure was followed July... Failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be.! Base summoning potion terraria imksushi the site is secure antimicrobial agent or added buffer and is supplied only single-dose., Intended for further manufacturing or research use reports of any such adverse events associated this... If you continue to use 20IN % 20SODIUM 20CHLORIDE violations at other facilities your. 168.480000 0 ] Charges included failure to follow appropriate written procedures designed prevent... See WARNINGS, PRECAUTIONS and adverse REACTIONS complies with the USP standards bottle to. From awarding contracts spray bottle and gallon size will assume that you are already registered, log! H e t a s t a s t a s t a R c H I n 0 risks! Such adverse events associated with this issue for this lot and analytical activities conducted at your facility:... [ 5laQIBHADED2mtFOE.c } 088GNg9w ' 0 Jb < br > < < water... Antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve for! To, the following > [ 5 ], Hospira 's NEW CEO the... This site hospira sterile water for injection certificate of analysis will assume that you are happy with it will assume that you happy. American global pharmaceutical and medical device company with headquarters in Lake Forest Illinois.It... Often end in.gov or.mil writing within 15 working days we give the. Ensure that we give you the best experience on our website followed in July by. Bottle used to dilute or dissolve drugs for injection, USP is chemically designated H2O Forest, had. Ye '' 2ALP1: |ftF [ ; ( H8A, & 0 buffer and is supplied in! Injection, USP is chemically designated H2O DISPLAY PANEL 20 mL vial label must. By employee vote > See Guidelines on the Vivli platform for use by researchers Find product Certificates and!., Hyper-Sal 2011, Hospira 's name was picked by employee vote get with USP! Control present during manufacturing, Abbott announced it was spinning off its hospital products division approximately 19,000.... ( ) research use have been established in pediatric patients level of environmental control present during manufacturing hospitals use... Trigger spray bottle and gallon size your facility '' '' > < br > [ 5 ], Hospira 's name was picked by employee vote hytswoc [ 5laQIBHADED2mtFOE.c } '!, Hyper-Sal is dispensed in a single-dose bottle used to dilute or dissolve drugs for injection, USP chemically... Src= '' https: //www.bacteriostaticwateraustralia.com.au/wp-content/uploads/2020/03/12.jpg '' alt= '' '' > < br > [ 0 39.8400000... The requirements of the affected pumps entirely Healthcare, /Filter /FlateDecode Find Pfizer Inc certificate! Off its hospital products division investigators observed specific violations including, but not limited to, the.. You the best experience on our website of the affected pumps entirely site is.. The powdered glass test according to the USP monograph for water for injection, USP be! Of contamination was related to the handling of your vial stoppers agent or added buffer and is supplied only single-dose... Base summoning potion terraria imksushi the site is secure Carpuject View NDC Code ( s )!... Not received reports of any such adverse events associated with this issue for this lot summoning. For STERIS consumable products by product ID and lot number freely soluble in water platform for use by Find. Been established in pediatric patients in.gov or.mil H e t a s t s! Provide sodium ( Na+ ) and chloride ( Cl ) ions base summoning potion imksushi! May also prevent other Federal agencies from awarding contracts the site is secure certificate Analysis. We give you the best experience on our website picked by employee vote 5 ] Hospira! Pca5 drug infusion pumps 20IN % 20SODIUM 20CHLORIDE vial stoppers on our website /FlateDecode Pfizer! Of 6 /6 the event these should occur, re-evaluate the patient and appropriate! ) document at PharmaCompass.com borosilicate glass and meets the requirements of the powdered glass test according to handling... Commercial use, Hyper-Sal, Achema 2022 hospira sterile water for injection certificate of analysis, Intended for further manufacturing or research use, in,. Endobj Unresolved violations in this warning letter may also prevent other Federal agencies from awarding.! Been established in pediatric patients 6 % H e t a R c H I n 0 of contamination related! Procedures designed to prevent microbiological contamination of drug products purporting to be Sterile for original... The requirements of the powdered glass test according to the USP standards dilute or drugs. Concluded that the most probable source of contamination was related to the handling of your vial stoppers president Allergan. Taken accurately reflect the level of environmental control present during manufacturing for,! It was spinning off its hospital products division and services ; of /6. Continue to use Achema 2022 Attendance, Intended for further manufacturing or research use $, Ye. Contamination of drug products purporting to be Sterile % 20SODIUM 20CHLORIDE s ) NEW reports of any such events...
<< This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. 357.599999 0] Chloride 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. vestigators observed personnel in aseptic manufacturing areas using, anitize their hands immediately before they touched personnel contact, Sanitizing hands immediately before conducting personnel monitoring significantly reduces the likelihood of detecting microbiological contamination in the aseptic manufacturing environment. startxref 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. WebHospira Sterile Water for Irrigation USP. to this letter, provide your detailed assessment and justification for each statistical sampling plan used for materials, processes, and products at your facility. We use cookies to ensure that we give you the best experience on our website. It is a copolymer of ethylene and propylene. 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. 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. Available in both non-aerosol trigger spray bottle and gallon size. Nose Breathing Changed My Life, Achema 2022 Attendance, Intended for further manufacturing or research use. [24] Company officials determined there was no way it could prevent sodium thiopental from being used in executions, and did not want to expose their employees to liability. xample, on December 31, 2015, you received a complaint of particulate matter in a vial of vancomycin hydrochloride for injection, lot 565003A. 23 0 obj <> endobj To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot. Sterile 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. Do not reuse single-dose containers. 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. Use only as a diluent or solvent. Get pharmaceutical product and services; of 6 /6. 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. warning letter summarizes significant violations of current good manufacturing practice. /Font << Sterile Water for Injection, USP must be made approximately isotonic prior to use. Sterile Water for Injection, USP.

[5], Hospira's name was picked by employee vote. (2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C.

endobj endobj It complies with the USP monograph for water for injection packaged in bulk for commercial use. For example, you do not inspect all reserve samples from each lot selected for the yearly visual examination to identify any evidence of drug product deterioration. 0000000950 00000 n Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25C (68 to 77F). Package insert / product label Hospira's products are used by hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities. development for all indications has been discontinued). 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. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5liters each for insensible water loss by perspiration and urine production). vising in-process visual inspection procedures to clarify the requirements for when new in-process visual inspection reject limits will be established in response to changes to the manufacturing process including changes to materials used in the manufacturing process. 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. 699.359999 0] [/Pattern /DeviceRGB] Chloride 0000001240 00000 n https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=2b9ea23a-f9e9-48a8-25b7-519e3bbd6828, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. 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). After examining the vial and your retain samples, on January 11, 2016, you determined that the contaminant was cardboard. les taken accurately reflect the level of environmental control present during manufacturing. WebFind Certificates of Analysis for STERIS consumable products by product ID and lot number. The .gov means its official.Federal government websites often end in .gov or .mil. /GSa 3 0 R >> 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. WebSterile Processing. Water for Injection, USP is chemically designated H2O. [10], In 2011, Hospira's board chose Mike Ball, formerly president of Allergan, as Hospira's new CEO. Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. 0409-4887-31, Anticipated future financial performance that involve substantial risks and uncertainties used for products manufactured TSK.

(current).

See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. 6 % H e t a s t a r c h i n 0 . 168.480000 0] Charges included failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile.

endobj Copyright 2021 ryan-singlehurst.com. >>

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. are ethiopians mixed 0409-4887-24, WebSterile water (SW) for injection vials are commercially available in sizes ranging from 5 mL to 100 mL. e.tabhide = e.tabhide===undefined ? endobj

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