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).

Recall Number: D-0182-2026

Firm: Fresenius Kabi USA, LLC

Classification: Class I

Status: Ongoing

Report Date: 20251203

Initiation Date: 20251106

Termination Date:

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

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).