FDA Drug Class I — Most Serious

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

Hazard

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

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Products

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
Brand
Impax Laboratories, Inc.
UPC
Lot Number 502240, expiry date 11/2017

Units Affected

3,074 boxes (30 count boxes)

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