Drug 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
D-0215-2017
Product summary
- Event
- Event 74953
- Status
- Terminated
- Classification
- Class I
- Quantity
- 3,074 boxes (30 count boxes)
- Official record key
drug-enforcement:D-0215-2017
Official wording
Reason: Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Code information: Lot Number 502240, expiry date 11/2017
Distribution pattern: Distributed Nationwide
Derived failure modes
-
Labeling or packaging
Labeling; Label Mixup