Fresenius Kabi USA, LLC recalls 2,199,850 vials of Famotidine Injection, U.S. distribution nationwide plus Alaska, Hawaii and Puerto Rico after endotoxin testing concerns. The microbial contamination risk prompted an immediate stop-use order. Healthcare providers and patients should follow recall guidance and seek alternatives through their providers.
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider for guidance. Notification method: Letter
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Famotidine Injection is a hospital medication used to reduce stomach acid production. It is administered by healthcare professionals in clinical settings.
Contaminated sterile injections pose risk of severe infection or endotoxin-related reactions if administered.
This recall is not part of a broader industry pattern, based on the current notice.
Hospitals and clinics must identify affected lots and replace or discard these vials. Consumers may face delays in treatment if alternatives are not readily available.
Identification is on the vial label and the accompanying packaging. FDA recall notices also list the lot numbers.
Refunds or replacements are coordinated through Fresenius Kabi and healthcare facilities; timelines vary by institution.
Keep recall letters, batch numbers, and any correspondence with suppliers or healthcare providers.
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials. NDC 63323-739-11 (unit of use) and 63323-739-12 (unit of sale). Quantity: 2,199,850 vials. Sold nationwide in the United States, including AK, HI, and PR. Lot numbers include 6133156, 6133194, 6133388. Expiry dates listed as 08/2026 and 10/2026.
No specific injuries or illnesses are described in the recall notice. The action is precautionary and based on quality testing results.
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