Drug product
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1
D-0483-2026
Product summary
- Event
- Event 98690
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 81,520 units
- Official record key
drug-enforcement:D-0483-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot Number: EA038A5, Expiration Date: 08/2026.
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility