Why it was recalled
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
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
Lot numbers, UPCs & expiration codes
Lot Number 502240, expiry date 11/2017
Where it was sold
Distributed Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0215-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 19, 2016
- FDA report date
- Dec 28, 2016
- Quantity
- 3,074 boxes (30 count boxes)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Impax Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0215-2017, exactly as published.
Show all FDA fields
- City
- Hayward
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 74953
- Address
- 31153 San Antonio Street
- Code information
- Lot Number 502240, expiry date 11/2017
- Postal code
- 94544
- Report date
- Dec 28, 2016
- Product type
- Drugs
- Recall number
- D-0215-2017
- Classification
- Class I
- Recalling firm
- Impax Laboratories, Inc.
- Product quantity
- 3,074 boxes (30 count boxes)
- Termination date
- Jun 1, 2017
- Reason for recall
- Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed Nationwide
- Recall initiation date
- Aug 19, 2016
- Initial firm notification
- Letter
- Center classification date
- Dec 22, 2016