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| The United States: Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP (English only) |
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The US Food and Drug Administration (FDA) announces that 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 to 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.
Elevated endotoxin levels can precipitate severe systemic reactions such as sepsis and septic shock. Severe responses may include inflammatory and life-threatening immune responses and death. Non-serious adverse event reports potentially associated with the OOS have been received for one lot. These non-serious adverse events included chills, change in mental status, change in respiratory status, fever, increase in body temperature, shivering and shaking. To date, no adverse event reports have been received for the second and third lots.
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:
1. Short term treatment of active duodenal ulcer.
2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.
3. Short term treatment of active benign gastric ulcer.
4. Short term treatment of gastroesophageal reflux disease (GERD).
5. Treatment of pathological hypersecretory conditions.
Please refer to the following website in FDA for details: http://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
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Saturday, 8 Nov, 2025
Issued at HKT 12:00
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