Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
| Source | FDA Drug Enforcement |
|---|---|
| Category | Drug |
| Severity | High |
| Status | ongoing |
| Recall date | November 06, 2025 |
| Reported | December 03, 2025 |
| Recalling firm | Fresenius Kabi USA, LLC |
| Country / region | United States IL |
Hazard
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Affected products
- Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sa
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