May 2020 FDA Recall Drug by Jubilant Cadista Pharmaceuticals, Inc.
D-1281-2020 - Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.

This Class III drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals, Inc. on May 26, 2020 for the product Drug. The FDA reported the reason for recall as presence of foreign substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.. The product was distributed in TN and the recall is currently terminated.

Recall Number: D-1281-2020

Reason for Recall
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Initiated
05-26-2020
Reported
06-03-2020
Quantity
1,313,333 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85752
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-15-2022
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

Lot# s 19P0437 & 19P0438, Exp. 09/30/2021.