FDAClass IIIJune 10, 2020

Lamotrigine Tablets recall

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.…

Why was Lamotrigine Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.…
Recalling firm
AVKARE Inc.
Quantity
4124 bottles
Distribution
Nationwide in the U.S.
Recall date
June 10, 2020
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls