Why it was recalled
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Product description
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.
Lot numbers, UPCs & expiration codes
Lot #: a) 25634, b) 25633; Exp. 09/30/2021
Where it was sold
Nationwide in the U.S.
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-1289-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 28, 2020
- FDA report date
- Jun 10, 2020
- Quantity
- 4124 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-1289-2020, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 85783
- Address
- 615 N 1st St
- Code information
- Lot #: a) 25634, b) 25633; Exp. 09/30/2021
- Postal code
- 38478-2403
- Report date
- Jun 10, 2020
- Product type
- Drugs
- Recall number
- D-1289-2020
- Classification
- Class III
- Recalling firm
- AVKARE Inc.
- Product quantity
- 4124 bottles
- Termination date
- Oct 22, 2021
- Reason for recall
- Presence of Foreign Substance consistent with granules from desiccant packs used during storage
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- May 28, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 4, 2020