AVKARE Inc.: Drug Recall

Recall #D-1329-2022 · 07/20/2022

Class III: Low Risk

Recall Details

Recall Number
D-1329-2022
Classification
Class III
Product Type
Drug
Recalling Firm
AVKARE Inc.
Status
Terminated
Date Initiated
07/20/2022
Location
Pulaski, TN, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8328 bottles

Reason for Recall

Labeling: Label Error on Declared Strength

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

Distribution Pattern

Nationwide within the United States

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.