Lamotrigine Orally Disintegrating Tablets recall: Labeling Error
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
Why was Lamotrigine Orally Disintegrating Tablets recalled?
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number 502240, expiry date 11/2017
- 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
- Recalling firm
- Impax Laboratories, Inc.
- Quantity
- 3,074 boxes (30 count boxes)
- Distribution
- Distributed Nationwide
- Recall date
- December 28, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)