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.
Reason for recall: Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Recall initiated: 20200526
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated