Drug product
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
D-1329-2022
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 90637
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8328 bottles
- Official record key
drug-enforcement:D-1329-2022
Official wording
Reason: Labeling: Label Error on Declared Strength
Code information: Lot #: 42581 Exp. 12/2024; 42484 Exp. 11/2024; 41204 Exp. 05/2024; 38723 Exp. 02/2023; 37623 Exp. 10/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Labeling or packaging
Labeling: Label Error