D-0215-2017 Class I Terminated
FDA drug recall D-0215-2017 was initiated by Impax Laboratories, Inc. on August 19, 2016 and is designated Class I. Reason for recall: Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs The recall status is terminated (terminated June 1, 2017). Affected quantity: 3,074 boxes (30 count boxes).
Recall Details
- Product Type
- Drugs
- Report Date
- December 28, 2016
- Initiation Date
- August 19, 2016
- Termination Date
- June 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,074 boxes (30 count boxes)
Product Description
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
Distribution Pattern
Distributed Nationwide
Code Information
Lot Number 502240, expiry date 11/2017