Why it was recalled
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Product description
Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.
Lot numbers, UPCs & expiration codes
Lot #: 331771, Exp. June 2021
Where it was sold
Nationwide in the U.S. and Puerto Rico.
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-0833-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 20, 2019
- FDA report date
- Feb 19, 2020
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0833-2020, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 84645
- Address
- 3 Skyline Dr
- Code information
- Lot #: 331771, Exp. June 2021
- Postal code
- 10532-2174
- Report date
- Feb 19, 2020
- Product type
- Drugs
- Recall number
- D-0833-2020
- Classification
- Class I
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Termination date
- Feb 23, 2024
- Reason for recall
- Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.
- Distribution pattern
- Nationwide in the U.S. and Puerto Rico.
- Recall initiation date
- Dec 20, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 7, 2020