AVKARE Inc. recalls Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50,…

Recall date

May 28, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1289-2020

FDA classification

Class III

Brand / firm

AVKARE Inc.

Sold / distributed

Nationwide in the U.S.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.