Drug product
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.
D-1289-2020
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 85783
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4124 bottles
- Official record key
drug-enforcement:D-1289-2020
Official wording
Reason: Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Code information: Lot #: a) 25634, b) 25633; Exp. 09/30/2021
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance