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FDARecalled Dec 3, 2025 · #D-0182-2026

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).

Hazard

Class I — serious health risk

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Description

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. Classification: Class I Distribution: Nationwide within the United States as well as AK, HI, and PR.

Product details

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).
Type
Drugs
Manufacturer
Fresenius Kabi USA, LLC
Model numbers
6133156
UPCs