Why it was recalled
Labeling: Label Error on Declared Strength
Product description
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
Lot numbers, UPCs & expiration codes
Lot #: 42581 Exp. 12/2024; 42484 Exp. 11/2024; 41204 Exp. 05/2024; 38723 Exp. 02/2023; 37623 Exp. 10/2022
Where it was sold
Nationwide within the United States
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-1329-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 20, 2022
- FDA report date
- Aug 17, 2022
- Quantity
- 8328 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-1329-2022, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 90637
- Address
- 615 N 1st St
- Code information
- Lot #: 42581 Exp. 12/2024; 42484 Exp. 11/2024; 41204 Exp. 05/2024; 38723 Exp. 02/2023; 37623 Exp. 10/2022
- Postal code
- 38478-2403
- Report date
- Aug 17, 2022
- Product type
- Drugs
- Recall number
- D-1329-2022
- Classification
- Class III
- Recalling firm
- AVKARE Inc.
- Product quantity
- 8328 bottles
- Termination date
- Sep 30, 2024
- Reason for recall
- Labeling: Label Error on Declared Strength
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 20, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 8, 2022