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

FDA recall notice · announced December 28, 2016 · Impax Laboratories

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

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

Reason for recall

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

Notes

Distribution: Distributed Nationwide
Lot/code information: Lot Number 502240, expiry date 11/2017
Quantity: 3,074 boxes (30 count boxes)
Status: Terminated
Products in this recall event:
- 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 (D-0215-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.