Drug product
Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97.
D-1281-2020
Product summary
- Event
- Event 85752
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,313,333 tablets
- Official record key
drug-enforcement:D-1281-2020
Official wording
Reason: Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Code information: Lot #s 19P0437 & 19P0438, Exp. 09/30/2021.
Distribution pattern: TN
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance