August 2016 FDA Recall Lamotrigine by Unichem Pharmaceuticals Usa Inc
D-1519-2016 - Tablets/Capsules Imprinted With Wrong ID
This Class III drug recall was voluntarily initiated by Unichem Pharmaceuticals Usa Inc on August 19, 2016 for the product Lamotrigine. The FDA reported the reason for recall as tablets/capsules imprinted with wrong id. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1519-2016
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
08-19-2016
10-05-2016
368 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.
Unichem Pharmaceuticals Usa 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
02-07-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.
Batch or Lot Expiration Information
Lot# : GLEH 16003, Exp 03/31/18
