D-1281-2020 Class III Terminated
FDA drug recall D-1281-2020 was initiated by Jubilant Cadista Pharmaceuticals, Inc. on May 26, 2020 and is designated Class III. Reason for recall: Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product. The recall status is terminated (terminated November 15, 2022). Affected quantity: 1,313,333 tablets.
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.