FDAFDA · Food and drugs·Recall number D-0215-2017
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
Published December 28, 2016 · Recall initiated: August 19, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Impax Laboratories, Inc.
- Distributor
- Distributed Nationwide
- Lot
- Lot Number 502240, expiry date 11/2017
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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