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Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bot...

FDA Recall #D-1289-2020 — Class III — May 28, 2020

Recall #D-1289-2020 Date: May 28, 2020 Classification: Class III Status: Terminated

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

Recalling Firm

AVKARE Inc. — Pulaski, TN

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

4124 bottles

Distribution

Nationwide in the U.S.

Code Information

Lot #: a) 25634, b) 25633; Exp. 09/30/2021

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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