Famotidine Injection recalled due to Out-of-specification Endotoxin Results, USA

United States

Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL vial. This recall is being performed at the user level in the United States.

The product is being recalled due to out-of-specification (OOS) endotoxin results of certain reserve samples from a single lot. Based upon the investigation, two additional lots were also included in the recall as a precautionary measure.

Affected Product:

PRODUCT: Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL fill in a 2 mL vial
SIZE: 2 mL vial
UNIT OF USE NDC: 63323-739-11
UNIT OF SALE NDC: 63323-739-12
PRODUCT CODE: 730912
BATCH NUMBERS: 6133156; 6133194; 6133388
EXPIRATION DATES: 08/2026; 10/2026
FIRST SHIP DATES: 01/02/2025; 02/04/2025; 05/23/2025
LAST SHIP DATES: 02/11/2025; 04/11/2025; 05/23/2025

Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short-term use in patients who are unable to take oral medication for the following conditions:

- Short-term treatment of an active duodenal ulcer.
- Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.
- Short-term treatment of an active benign gastric ulcer.
- Short-term treatment of gastroesophageal reflux disease (GERD).
- Treatment of pathological hypersecretory conditions.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-three-lots-famotidine-injection-usp-20-mg-2-ml-10