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FDAAugust 19, 2016drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

impax laboratoriesimpax

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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