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Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pula...

FDA Recall #D-1329-2022 — Class III — July 20, 2022

Recall #D-1329-2022 Date: July 20, 2022 Classification: Class III Status: Terminated

Product Description

Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4

Reason for Recall

Labeling: Label Error on Declared Strength

Recalling Firm

AVKARE Inc. — Pulaski, TN

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

8328 bottles

Distribution

Nationwide within the United States

Code Information

Lot #: 42581 Exp. 12/2024; 42484 Exp. 11/2024; 41204 Exp. 05/2024; 38723 Exp. 02/2023; 37623 Exp. 10/2022

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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