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.

FDA recall notice · announced June 3, 2020 · Jubilant Cadista Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: TN
Lot/code information: Lot #s 19P0437 & 19P0438, Exp. 09/30/2021.
Quantity: 1,313,333 tablets
Status: Terminated
Products in this recall event:
- 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, Bul (D-1281-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.