Recalls / Class III
Class IIID-1329-2022
Product
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
- Brand name
- Lamotrigine
- Generic name
- Lamotrigine
- Active ingredient
- Lamotrigine
- Route
- Oral
- NDCs
- 42291-366, 42291-367, 42291-368, 42291-369
- FDA application
- ANDA079132
- Affected lot / code info
- Lot #: 42581 Exp. 12/2024; 42484 Exp. 11/2024; 41204 Exp. 05/2024; 38723 Exp. 02/2023; 37623 Exp. 10/2022
Why it was recalled
Labeling: Label Error on Declared Strength
Recalling firm
- Firm
- AVKARE Inc.
- Manufacturer
- AvKARE
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 8328 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-07-20
- FDA classified
- 2022-08-08
- Posted by FDA
- 2022-08-17
- Terminated
- 2024-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1329-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.