Drug 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).
D-0182-2026
Product summary
- Event
- Event 97945
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 2,199,850 vials
- Official record key
drug-enforcement:D-0182-2026
Official wording
Reason: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Code information: Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Distribution pattern: Nationwide within the United States as well as AK, HI, and PR.
Derived failure modes
-
Microbial contamination
Microbial Contamination