recall
saveFresenius Kabi USA, LLC recall (Cls I)
December 3, 2025updated 6mo ago
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Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale). — Reason: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. — Status: Ongoing
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same company · ±60 days · 6
- approvalDALBAVANCIN HYDROCHLORIDE — FDA approvalNov 26, 2025
- device recallFresenius Kabi USA, LLC device recall (Cls II)Nov 21, 2025
- approvalPROPOFOL: DIPRIVAN (PROPOFOL) — FDA approvalNov 21, 2025
- approvalHYDROMORPHONE HYDROCHLORIDE: DILAUDID-HP (HYDROMORPHONE HYDROCHLORIDE) — FDA approvalDec 22, 2025
- approvalKapanol: MORPHINE SULFATE — FDA approvalDec 22, 2025
- device recallFresenius Kabi USA, LLC device recall (Cls I)Nov 14, 2025
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