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
Reported: December 28, 2016 Initiated: August 19, 2016 #D-0215-2017
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
Details
- Recalling Firm
- Impax Laboratories, Inc.
- Units Affected
- 3,074 boxes (30 count boxes)
- Distribution
- Distributed Nationwide
- Location
- Hayward, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Impax Laboratories, Inc.. Units affected: 3,074 boxes (30 count boxes).
Why was this product recalled? ▼
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 28, 2016. Severity: Critical. Recall number: D-0215-2017.
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