Impax Laboratories, Inc. recalls Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Man…

Recall date

August 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0215-2017

FDA classification

Class I

Brand / firm

Impax Laboratories, Inc.

Sold / distributed

Distributed Nationwide

Why it was recalled

Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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