Recalls / Class III
Class IIID-1281-2020
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.
- Affected lot / code info
- Lot #s 19P0437 & 19P0438, Exp. 09/30/2021.
Why it was recalled
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, N/A, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 1,313,333 tablets
- Distribution pattern
- TN
Timeline
- Recall initiated
- 2020-05-26
- FDA classified
- 2020-05-29
- Posted by FDA
- 2020-06-03
- Terminated
- 2022-11-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1281-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.