August 2016 FDA Recall Drug by Impax Laboratories, Inc.
D-0215-2017 - Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs

This Class I drug recall was voluntarily initiated by Impax Laboratories, Inc. on August 19, 2016 for the product Drug. The FDA reported the reason for recall as labeling; label mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0215-2017

Reason for Recall
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Initiated
08-19-2016
Reported
12-28-2016
Quantity
3,074 boxes (30 count boxes)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74953
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Impax Laboratories, 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.
Distributed Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-01-2017
Product Description About Product Description
Full technical description of the product.
Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA

Batch or Lot Expiration Information

Lot# Lot Number 502240, expiry date 11/2017