Dr. Marty Makary, Commissioner of Food and Drugs Administration | FDA
Fresenius Kabi has announced a voluntary recall of three lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), due to out-of-specification endotoxin results in reserve samples from one lot. The affected lot numbers are 6133156, 6133194, and 6133388. The recall is being carried out at the user level across the United States.
According to the company, elevated levels of endotoxins can cause severe systemic reactions such as sepsis and septic shock. These responses may include life-threatening immune reactions and death. Fresenius Kabi reported that non-serious adverse events have been linked to one lot, including chills, changes in mental and respiratory status, fever, increased body temperature, shivering, and shaking. No adverse events have been reported for the other two lots so far.
The recalled product is used in hospitalized patients with certain gastrointestinal conditions or as an alternative for those unable to take oral medication. It is indicated for short-term treatment of active duodenal ulcer, maintenance therapy after healing of an ulcer at reduced dosage, short-term treatment of benign gastric ulcer and gastroesophageal reflux disease (GERD), and treatment of pathological hypersecretory conditions.
Fresenius Kabi is informing distributors and customers about the recall and organizing the return of affected products. Health care facilities with any units from these lots are instructed to stop distributing or using them immediately and return all units to Fresenius Kabi. Distributors should also notify their customers who may have received the recalled product.
Consumers with questions can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459 during business hours. Patients experiencing problems related to this drug should consult their health care provider.
Adverse reactions or quality issues related to this product can be reported directly to Fresenius Kabi Medical Affairs or Vigilance departments by phone or email. Additionally, incidents can be reported to the FDA’s MedWatch Adverse Event Reporting program online (www.fda.gov/medwatch/report.htm), by mail or fax using forms available on www.fda.gov/MedWatch/getforms.htm or by calling 1-800-332-1088.
"This recall is being conducted with the knowledge of the U.S. Food and Drug Administration."
