Drug product
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
D-0590-2025
Product summary
- Firm
- PFIZER INC
- Event
- Event 97364
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 49,620 vials
- Official record key
drug-enforcement:D-0590-2025
Official wording
Reason: Lack of Assurance of Sterility.
Code information: Lot #: LY3681, LY4360, LY4416, Exp. 02/28/2026
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility