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.

FDA recall notice · announced June 10, 2020 · Avkare

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Notes

Distribution: Nationwide in the U.S.
Lot/code information: Lot #: a) 25634, b) 25633; Exp. 09/30/2021
Quantity: 4124 bottles
Status: Terminated
Products in this recall event:
- 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. (D-1289-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.