FDA-Drug2025-12-03Class I
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).
Fresenius Kabi USA, LLC
Hazard
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Sold states
Nationwide within the United States as well as AK, HI, and PR.
Affected count
2,199,850 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0182-2026Don't want to check this manually?
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