D-1289-2020 Class III Terminated
FDA drug recall D-1289-2020 was initiated by AVKARE Inc. on May 28, 2020 and is designated Class III. Reason for recall: Presence of Foreign Substance consistent with granules from desiccant packs used during storage The recall status is terminated (terminated October 22, 2021). Affected quantity: 4124 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 10, 2020
- Initiation Date
- May 28, 2020
- Termination Date
- October 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4124 bottles
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.
Reason for Recall
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #: a) 25634, b) 25633; Exp. 09/30/2021