Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 4229
Summary
The FDA issued a Class III for Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: by AVKARE Inc.. Reason: Labeling: Label Error on Declared Strength.
Details
Source
Drug Recall
External ID
D-1329-2022
Action Date
2022-08-17
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #: 42581 Exp. 12/2024; 42484 Exp. 11/2024; 41204 Exp. 05/2024; 38723 Exp. 02/2023; 37623 Exp. 10/2022
Quantity Affected: 8328 bottles
Reason for Recall
Labeling: Label Error on Declared Strength
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-20
Company
Pulaski, TN
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 41 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AVKARE Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AVKARE Inc. have FDA actions?
This is the only FDA action we have on record for AVKARE Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1329-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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