May 2020 FDA Recall Lamotrigine by Avkare Inc.
D-1289-2020 - Presence of Foreign Substance consistent with granules from desiccant packs used during storage
This Class III drug recall was voluntarily initiated by Avkare Inc. on May 28, 2020 for the product Lamotrigine. The FDA reported the reason for recall as presence of foreign substance consistent with granules from desiccant packs used during storage. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1289-2020
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
05-28-2020
06-10-2020
4124 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AVKARE Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S.
10-22-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.
Batch or Lot Expiration Information
Lot# : a) 25634, b) 25633; Exp. 09/30/2021
