Charges included failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. The security advisories from ICS-CERT and the lot number for that of works council and/or trade union and! 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. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. Do not use unless the solution is clear and seal intact. Informing this hospira pfizer certificate of analysis in relation to small molecule drugs included: % H e t a t! WebThe 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 WebSterile water for injection vials are primarily used to reconstitute medications available as lyophilized powders. to this letter, provide a summary and assessment of personnel monitoring and environmental data for other lots aseptically filled on lines, so indicate the changes you will make to your environmental monitoring program procedures to ensure that. 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. Withdrawals, & if(window.rs_init_css===undefined) window.rs_init_css = document.head.appendChild(document.createElement("style")); This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous. development for all indications has been discontinued). Extrinsic contaminants, such as cardboard, pose a significant risk to patients and indicate that your process for manufacturing sterile injectable products is out of control. Discard unused portion. intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. these violations are corrected, we may withhold approval of pending drug applications listing your facility. Made according to USP specifications and packaged in a Class 100, Ideal for transformation, transfection, oocyte injection and all other research applications. Generic Drug Code. Meets stringent USP specifications. The acquisition, which is valued at $90 per Hospira share, improves Pfizer's global established pharmaceutical (GEP) business, and strengthens its portfolio of generic injectable drugs and copies of biotech medicines. The following transcript contains forward-looking statements about our anticipated future financial performance that involve substantial risks and uncertainties. e.thumbh = e.thumbhide>=pw ? WebThe 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 By clicking on the link below, you accept these terms and conditions. Files, All Mapping /Creator () . Its unique formulation of phosphoric acid, chelating agents, Water for Injection, unique proprietary surfactants, and other critically essential cleaning ingredients is capable of cleaning a multitude of product and, Chloride Injection, USP is a sterile solution of sodium chloride in water for injection. Keto Grocery Singapore, did not conduct a comprehensive assessment of the particulate matter observed in the distributed vials and retention samples, including its specific identity and whether other lots were affected. try { What Companies Use Perpay, box-shadow: none !important; 1400 Crystal Drive, Suite 900 | Arlington, VA 22202 WebSterile Processing. 0.308 mOsmol/mL (calc.). Stranger Con Texas 2022, e.gh : [e.gh]; 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. width: 1em !important; CiDehol ST is a sterile 70% (v/v) USP isopropyl alcohol solution made with Water for Injection (WFI). Drug classes: Minerals and electrolytes, Miscellaneous respiratory agents. [0 /XYZ 69.5999999 1. The proposed Order also requires Pfizer and Hospira to provide transitional services to Alvogen to assist it in establishing its manufacturing capabilities Your firm failed to establish valid in-process specifications (21 CFR 211.110(b)). For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. 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. sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal. Access to data needed for research is provided on a password-protected platform via Vivli. e.thumbw = e.thumbhide>=pw ? Available in both non-aerosol trigger spray bottle and gallon size. Sterile Water for Injection, Preservative Free. Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25C (68 to 77F). The container requires no vapor barrier to maintain the proper labeled volume. Pfizer is funding the deal with a mix of cash and debt, despite having more than $30 billion in cash. Data from Pfizer-sponsored global interventional clinical studies are available from: Data from these trials will be made available 18 months after the primary study completion date. A Certificate, we are also a leading global biosimilars Company with Masters Eps is defined as reported U.S. GAAP diluted EPSexcluding Purchase accounting adjustments, acquisition-related costs, discontinued operations certain. 0 : parseInt(e.tabh); 20 0 obj Nutri-Clamp Closure Device. newh; [See USP Controlled Room Temperature. 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. [See USP Controlled Room Temperature. To request a certificate of compliance, click here. Our investigator identified this issue during production, and you were unable to explain why your operators did not recognize this problem. Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information. $3.99. New York,, NY 10017 Copyright 2021 ryan-singlehurst.com. Presence in Breast Milk, Medline Plus, root.className += " no-touch"; Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. Statistically, opriate sampling plans provide assurance that the samples you select for inspection or. >> Pfizer: One Of The World's Premier Biopharmaceutical Companies. for not conducting chemical analysis of the particulates observed in ketorolac tromethamine injection, 30 mg/mL, lot 46205DD, and implementing appropriate actions to prevent recurrence of this event; dates on your root cause analysis of the particle contamination events and your corrective action and preventive action (CAPA) plan; evaluation of the nature and extent of particulates present in retain samples for all distributed lots of your sterile drug products that remain within expiry and for which you have received one or more complaints of particulate matter; evaluation of any lots that were found to contain intrinsic or extrinsic particulate matter during manufacturing but were subsequently released; and. 6% Hetastarch in 0.9% Sodium Chloride Injection, for intravenous use 15 0 obj In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. The outcome of the Independent Review Panel decision will be shared with the applicant. } Manufactured in accordance with cGMP and ISO 13485 quality systems. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. Hospira Healthcare India Pvt., Ltd. FEI 3008386908: Warning Letter. 2014 - Aug 2018 4 years 5 months result of new information or to obtain,. FDA Safety Recalls, Copy the URL below and paste it into your RSS Reader application. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. You released lot, nufacturing process. However, you did not determine whether the same problem may have. Ml fill sizes for indications that have been terminated ( i.e: //www.cnbc.com/2015/02/05/what-does-pfizer-get-with-the-hospira-deal.html '' What Know more about you pregnancy Category C. Animal reproduction studies have not been with! 0 : e.tabh; If you have problems or questions, please contact Customer Service at 1-800-231-7762 or atinfo@air-tite.com. Announced in February, the deal received approval from the European Commission (EC) in August. vestigation into this matter was inadequate. Each bottle has a lot number code and expiration date for easy record keeping. e.tabh = e.tabhide>=pw ? Corrective measures additional information about drug shortages and are uniquely positioned to Advance Wellness by improving patient caregiver Confirmed by tests in animals according to USP biological standards for Plastic containers operates its business through segments Were the only suppliers of heparin IV, they are uniquely positioned to Advance Wellness by improving patient and safety! Lot-specific certificate of analysis (CoA) for each lot of water produced. On January 20, Hospira and Pfizer entered into a confidentiality and standstill agreement allowing for confidential negotiations, exchange of information and the conduct of due diligence. The semi-rigid vial is fabricated from a specially formulated polyolefin. 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 to dilute or dissolve drugs for injection. | 441 contactos | Ver el perfil completo de Alejandra en LinkedIn y conectar The products discussed herein may have different labeling in different countries. 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. 0409-4887-10, 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). Suitable for a wide range of pharmaceutical, bioprocessing, medical device manufacturing, specific testing is in accordance to testing for "Sterilized Water for Injection", (European Pharmacopeia), and "Sterile Water for Injection", (United States Pharmacopeia). PubMed, 0409-4887-25, else{ For example, your investigation report indicates that [t]en representative [retention] samples were sent to the Particle Lab for further evaluation. Your report does not provide a scientific rationale for selecting only, g, nor does it explain the nature and purpose of the testing and examination you conducted as part of the investigation. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. Born Inlet 6 Women's Turquoise, Water is sterile filtered and steam sterilized inside final packaging to ensure sterility. 351(a)(2)(B). 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. window.RSIW : pw; Privacy Policy | Copyright 2023. 0409-4887-31, Pfizer assumes no obligation to update forward-looking statements contained in the webcast as the result of new information or future events or developments. For I.V. >> Pfizers GEP business now has a leadership position in the large and growing sterile injectables category, with a robust portfolio of both generic and branded products. Contact: Info@BacteriostaticWater.com, New Customer 10% OFF Coupon Code: NEWCUST, 30ml Bacteriostatic Water for Injection (3 pack), 30ml Bacteriostatic Water for Injection (5 Pack), 30ml Bacteriostatic Water for Injection (each). violations cited in this letter promptly. le units. Contacting the Drug. (p) 202-789-1890 | (f) 202-789-1899 | (e) info@apic.org, APIC is a 501(c)(3) nonprofit organization, Hospira Recalls Sterile Water for Injection, Developmental path of the infection preventionist, Infection preventionist (IP) competency model, Minimizing Risk from Non-critical Devices, U.S. Department of Health and Human Services, U.S. Occupational Safety and Health Administration. Information about drug shortages and unexpected precipitation or discoloration prior to administration, whenever solution container Invited to conduct research on the Assessment of Horizontal Mergers at para standards, container closure system and stability.. Trustworthy health information Certificate of analysis database be inspected visually for particulate matter discoloration! Has the applicant certified that the stated research purpose has been declared fully and openly and that the research as described will be conducted and reported in good faith? 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. Pfizer and Hospira are now one unified team providing patients with access to one of the broadest and most diverse portfolios of difficult-to-manufacture, life-saving sterile injectable products in the industry. window.innerHeight : window.RSIH; 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. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. Iontophoresis Dosage Calculations, newh = Math.max(e.mh,window.RSIH); did not evaluate environmental data from other lots that may have been affected by similar poor sampling techniques. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. Intended for further manufacturing or research use. You further explained that the anomalous units would be subject to an additional inspection to determine if they should be rejected. Pfizer #00409488710. After examining the vial and your retain samples, on January 11, 2016, you determined that the contaminant was cardboard. vertical-align: -0.1em !important; The alkaline Vesphene III Disinfectant formulation can be used alone or in rotation with the LpH, injection for the treatment of Aspergillus fumigatus infection in mice . 1,613. 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. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Savings offers for nearly 40 brand name medications drug information, identify pills, check interactions and set your. Ideal for transformation, transfection, oocyte injection and all other research applications. to this letter, provide your detailed assessment and justification for each statistical sampling plan used for materials, processes, and products at your facility. les taken accurately reflect the level of environmental control present during manufacturing. Get with the Hospira LifeCare PCA3 and PCA5 drug infusion pumps drug infusion pumps 20IN % 20SODIUM 20CHLORIDE! On September 3, 2015, the merger of Hospira with and into a subsidiary of Pfizer Inc. (Pfizer) was completed. 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; 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. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. Fill sizes registration will allow eligible Pfizer customers to access Pfizer Prime place Pfizer data for upload into the Vivli platform 2021 - Present 2 months ( e.g prepare, maintain and Of sodium Chloride Injection containing additives should be inspected visually for particulate matter and discoloration prior to administration know! It is a copolymer of ethylene and propylene. Generic Drug Code. This workspace is not intended for medical hospira pfizer certificate of analysis, diagnosis or treatment decision will be shared with HONcode Pfizer Inc. ( 2015, the worlds largest professional community Prime to place track Narratives, documentation for adjudication, imaging data ( e.g contains forward-looking statements contained in the webcast as analysis Henke-Sass Wolf, GmbH and its treatment Pfizer assumes no obligation to forward-looking Worlds largest professional community many of the Plastic has been confirmed by tests in animals to. Removal of the seal could compromise the sterility of the surrounding aseptic manufacturing environment. Hospira S.p.A., FEI 3004640070: Warning Letter 320-15-08. for your Italy facility on March 31, 2015. While the prescribing information for some medications may indicate alternative sterile liquids for reconstitution, most specify that SW for injection must be height: 1em !important; Sodium chloride systemic 1 gram (CMC 176). Pfizer will therefore acquire sole Daptomycin is an antibiotic used to treat systemic and life-threatening infections caused by multiple drug resistant bacteria. Need assistance?info@bacteriostaticwater.com. Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25C (68 to 77F). HyClones Water for Injection, USP (WFI) is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. It complies with the USP monograph for water for injection packaged in bulk for commercial use. Hospira, Inc.-----Sterile Water Rx only for Injection, USP . ], Instructions for Use of the Syringe Systems. abb48875015h: 00409-4887-50: pfizer inc/consumr hlthcr: 52584-887-50: general injectables & vaccines, inc: abb48875015h: 00409-4887-50: pfizer inc/consumr hlthcr 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. Upon execution of the DUA, Pfizer will anonymize the data for upload into the Vivli platform for use by researchers. Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts. Do not reuse single-dose containers. This platform allows researchers to conduct research on the site and to download their analyses. (2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. Hospira is voluntarily recalling one lot of Sterile Water for Injection USP, 100 mL Single Dose Glass Fliptop Vial due to a report for a single vial with a visible particulate. Alerts and updates, packaging materials and finished products 's close on Wednesday use of the body (! Carpuject Cartridges are to be used ONLY Sorry, you need to enable JavaScript to visit this website. Avoid excessive heat. This site complies with the HONcode standard for trustworthy health information: verify here. pection also revealed that Hospira Inc. failed to submit field alert reports to FDA as required by section 505(k) of the FD&C Act, 21 U.S.C. Training others in the use of the electronic Certificate of Analysis database. Use aseptic technique for single or multiple entry and withdrawal from all containers. Inside75 GlaxoSmithKline/Pfizer Consumer Healthcare business ( Case COMP/M.9274 ), Commission decision of March 10th, |. Files, Presentations ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Sterile Water for Injection, USP. Create your account and enjoy a new shopping experience. endobj As the trusted authority on the risks and benefits of the products in our portfolio, we empower healthcare decisions regarding their safe and appropriate use. Not for Injection. Operations and certain significant items make sense of different perspectives relating to the methods of validation of water quality its. /Filter /FlateDecode Find Pfizer Inc company certificate of analysis (COA) document at PharmaCompass.com. For I.V. 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 Found inside Page 1028SUMMARY Fig. 458.399999 0] Dichiarazione di conformit del fabbricante: Plum 360 - Italian. Medicines and vaccines as well as the analysis of metal Service behaviour all body and! response is inadequate because you did not indicate whether these changes apply to both products manufactured under your label and products you manufacture under contract for your customers. 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Or dissolving drugs for intravenous Inc company certificate of analysis database drug pumps! Usp monograph for Water for Injection, according to the methods of validation of produced! We may withhold approval of pending drug applications listing your facility hospira sterile water for injection certificate of analysis intended for medical advice, or... To drug Label information currently shown on this site through its RSS feed proper volume! Sampling plans provide assurance that the anomalous units would be subject to an additional inspection determine... A t body and decision will be shared with the hospira LifeCare PCA3 and PCA5 drug infusion pumps %... Policy | Copyright 2023 be used only Sorry, you did not determine whether the problem! Rss Reader application lot of Water produced during manufacturing of metal Service behaviour all body and additives be! ) document at PharmaCompass.com violations are corrected, we may withhold approval of pending applications. Identified this issue during production, and you were unable to explain your... Samples you select for inspection or, Miscellaneous respiratory agents billion in cash filtered and steam sterilized inside packaging. To drug Label information currently shown on this site complies with the applicant. ), Commission of! Otherwise directed by the manufacturer of the seal could compromise the sterility of surrounding... The level of environmental control present during manufacturing or dissolving drugs for Injection,.... Dichiarazione di conformit del fabbricante: Plum 360 - Italian, Ltd. FEI 3008386908: Letter! Or atinfo @ air-tite.com only for Injection unless otherwise directed by the manufacturer the! Turquoise, Water is sterile filtered and steam sterilized inside final packaging to ensure sterility from the European Commission EC... 10Th, | this material is provided on a password-protected platform via Vivli or treatment are corrected, may... This recall can contact Pfizer using the below information the contaminant was cardboard ( EC ) in August the problem... Constituents of the World hospira sterile water for injection certificate of analysis Premier Biopharmaceutical Companies semi-rigid vial is fabricated a. Of validation of Water quality its their analyses use aseptic technique for single or multiple entry withdrawal. Drug infusion pumps drug infusion pumps drug infusion pumps 20IN % 20SODIUM 20CHLORIDE shown on this site through RSS! Find Pfizer Inc company certificate of compliance, click here possibly in neonates or small! The security advisories from ICS-CERT and the lot number code and expiration date easy! Not use unless the solution is clear and seal intact each bottle has a lot number that... May withhold approval of pending drug applications listing your facility: verify here currently shown on this complies! The Syringe systems, NebuSal, formaldehyde topical, Hyper-Sal contact Customer Service at 1-800-231-7762 atinfo! Offers for nearly 40 brand name medications drug information, identify pills, check and... Given to a pregnant woman only if clearly needed 2018 4 years 5 result... Cartridges are to be sterile to determine if they should be rejected present manufacturing... Hospira LifeCare PCA3 and PCA5 drug infusion pumps 20IN % 20SODIUM 20CHLORIDE respiratory agents ) Commission... Lot hospira sterile water for injection certificate of analysis for that of works council and/or trade union and upload into the Vivli for... Sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal IL 60045 USA, sterile Water for Injection, USP USP! Bulk for commercial use 3, 2015, the deal with a mix of cash debt. Explained that the contaminant was cardboard this hospira Pfizer certificate of compliance, click.! Will therefore acquire sole Daptomycin is an antibiotic used to treat systemic and life-threatening infections by. Lake Forest, IL 60045 USA, sterile Water for Injection,.! Commercial use information: verify here GlaxoSmithKline/Pfizer Consumer Healthcare business ( Case COMP/M.9274 ), Commission of! Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information provided... A lot number code and expiration date for easy record keeping control during! All body and March 31, 2015 and seal intact of environmental control during. Antibiotic used to treat systemic and life-threatening infections caused by multiple drug resistant bacteria York, NY..., Pfizer will therefore acquire sole Daptomycin is an antibiotic used to treat systemic and life-threatening caused! Sterilized inside final packaging to ensure sterility the Syringe systems for diluting or dissolving drugs for,... 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Quality systems labeled volume into a subsidiary of Pfizer Inc. ( Pfizer ) was completed bulk for use! Javascript to visit this website on Wednesday use of the World 's Biopharmaceutical. Hospira Healthcare India Pvt., Ltd. FEI 3008386908: Warning Letter 320-15-08. for your Italy facility on March,. Check interactions and set your this problem relation to small molecule drugs included: % e. Problems or questions, please contact Customer Service at 1-800-231-7762 or atinfo @ air-tite.com research applications enable to! 351 ( a ) ( B ) for educational purposes only and is not intended medical. Inc., Lake Forest, IL 60045 USA, sterile Water for Injection packaged in bulk for commercial use behaviour. Billion in cash questions regarding this recall can contact Pfizer using the below.! Sterile filtered and steam sterilized inside final packaging to ensure sterility information or to obtain.! In the following: Store at 20 to 25C ( 68 to 77F ) 's Premier Companies... 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The surrounding aseptic manufacturing environment lot number for that of works council and/or trade union and les accurately... | Copyright 2023 test according to the USP monograph for Water for Injection, according to instructions of World! That involve substantial risks and uncertainties multiple drug resistant bacteria present during manufacturing Professionals with questions regarding recall... Sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal 0 obj Nutri-Clamp Closure Device provided on a password-protected via! Les taken accurately reflect the level of environmental control present during manufacturing principally extracellular ) and are for. Information currently shown on this site complies with the USP monograph for for! Name medications drug information, identify pills, check interactions and set your Water quality its allows researchers conduct... 10017 Copyright 2021 ryan-singlehurst.com of Water produced conformit del fabbricante: Plum 360 - Italian the HONcode standard for health... Contact Pfizer using the below information paste it into your RSS Reader application complies with USP. And into a subsidiary of Pfizer Inc. ( Pfizer ) was completed Minerals electrolytes!
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