D-1281-2020 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 3, 2020
- Initiation Date
- May 26, 2020
- Termination Date
- November 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,313,333 tablets
Product Description
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.
Distribution Pattern
TN
Code Information
Lot #s 19P0437 & 19P0438, Exp. 09/30/2021.