Famotidine Injection Recalled for Endotoxin Concerns
This recall was posted 4 months ago. Check the FDA source for the latest status.
Class I Recall — Most Serious
This is a Class I recall — the most serious type. Products covered by this recall may cause serious health consequences or death.
Fresenius Kabi USA, LLC has announced a voluntary recall of three lots of Famotidine Injection, USP, 20 mg per 2 mL due to elevated endotoxin levels found in reserve samples. This recall affects products distributed across the United States.
Affected Products:
- Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vial
- Lot numbers: 6133156, 6133194, 6133388
Reason for Recall:
The recall was initiated after certain reserve samples showed out-of-specification endotoxin levels. High endotoxin levels can lead to severe reactions such as sepsis and septic shock, which may include inflammatory and life-threatening immune responses.
Health Risks:
Non-serious adverse events have been reported for one of the affected lots, including chills, changes in mental and respiratory status, fever, and shivering. No adverse events have been reported for the other two lots.
Consumer Guidance:
Healthcare facilities should immediately stop distributing, dispensing, or using the affected lots and return them to Fresenius Kabi. Distributors should notify their customers about the recall. Consumers with questions can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, 8:00 a.m. to 5:00 p.m. CST.
Patients who have experienced problems should contact their healthcare provider. Adverse reactions can be reported to Fresenius Kabi Medical Affairs at 1-800-551-7176 or to the FDA's MedWatch program.
Where Products Were Sold
This recall affects products distributed nationwide across the United States.