Drug product
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
D-0581-2026
Product summary
- Event
- Event 98997
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 898,050 vials
- Official record key
drug-enforcement:D-0581-2026
Official wording
Reason: Failed Impurities/Degradations Specifications
Code information: Batch # 6133313, 6133314, Exp Date: 06/2026; Batch # 6133315, Exp Date: 07/2026; Batch # 6133682, Exp Date: 09/2026; Batch # 6134812, 6134813, Exp Date: 04/2027.
Distribution pattern: US Nationwide.
Derived failure modes
-
Unknown
Failed Impurities/Degradations Specifications