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 for recall: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Recall initiated: 20251106
Status: Ongoing
Classification: Class I
Recall type: Voluntary: Firm initiated