Fresenius Kabi, a global healthcare company specializing in infusion, transfusion, and clinical nutrition therapies, has initiated a voluntary recall of three lots of Famotidine Injection, USP (20 mg/2 mL) in the United States. The affected lot numbers are 6133156, 6133194, and 6133388. The recall is being conducted to the user level.
Reason for the Recall
The recall was prompted by out-of-specification endotoxin results detected in reserve samples from one lot. Following the investigation, Fresenius Kabi included two additional lots as a precautionary measure.
Elevated endotoxin levels can cause severe systemic reactions, including:
- Sepsis
- Septic shock
- Strong inflammatory responses
- Potentially life-threatening immune reactions
One lot has been linked to non-serious adverse events, such as chills, fever, shivering, altered mental status, and respiratory changes. No adverse events have been reported for the remaining two lots.
Product Use
Famotidine Injection is typically used in hospitalized patients when oral administration is not possible, including:
- Short-term treatment of active duodenal ulcers
- Maintenance therapy following duodenal ulcer healing
- Short-term treatment of benign gastric ulcers
- Short-term treatment of GERD
- Treatment of pathological hypersecretory conditions
Instructions for Healthcare Providers
Fresenius Kabi has notified distributors and customers and initiated product returns.
Healthcare facilities are advised to:
- Stop distribution and use immediately
- Quarantine the affected lots
- Return all impacted units to Fresenius Kabi
Distributors must promptly notify all customers who may have received the recalled product.
