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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

Fresenius Kabi USA, LLC: Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

Agency Publication Date: December 10, 2014
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Affected Products

Product: MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.

Lot 6003827, Exp. Date 04/2015

Lot Numbers:
6003827
Product: ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02

Lot 6003930, exp. date 04/2014

Lot Numbers:
6003930
Product: CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-044-01.

Lot 6003853, exp. date 04/2014

Lot Numbers:
6003853

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 63451
Status: Resolved
Manufacturer: Fresenius Kabi USA, LLC
Manufactured In: United States
Units Affected: 3 products (101,200 Vials; 184,550 Vials; 240,550 Vials)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.