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.

Recall Number: D-1289-2020

Firm: AVKARE Inc.

Classification: Class III

Status: Terminated

Report Date: 20200610

Initiation Date: 20200528

Termination Date: 20211022

Presence of Foreign Substance consistent with granules from desiccant packs used during storage

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.