Drug product
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01
D-0494-2026
Product summary
- Event
- Event 98787
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 74,040 Single Dose Vials
- Official record key
drug-enforcement:D-0494-2026
Official wording
Reason: Labeling: Missing Label
Code information: Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Missing