D-1329-2022 Class III Terminated
FDA drug recall D-1329-2022 was initiated by AVKARE Inc. on Jul 20, 2022 and is designated Class III. Reason for recall: Labeling: Label Error on Declared Strength The recall status is terminated (terminated Sep 30, 2024). Affected quantity: 8328 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 17, 2022
- Initiation Date
- Jul 20, 2022
- Termination Date
- Sep 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8328 bottles
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
Reason for Recall
Labeling: Label Error on Declared Strength
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 42581 Exp. 12/2024; 42484 Exp. 11/2024; 41204 Exp. 05/2024; 38723 Exp. 02/2023; 37623 Exp. 10/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1329-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026