Fresenius Kabi USA, LLC: 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), 6332
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Fresenius Kabi USA, LLC
- Product
- 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 / hazard
- Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the United States as well as AK, HI, and PR.
- Recall initiated
- 2025-11-06
- Code info
- Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
- Product quantity
- 2,199,850 vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Lake Zurich
- State
- IL
- Country
- United States
- Event id
- 97945
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