Recall: D-1329-2022

Class III - Minor Violations

Class IIIClassification

2022-07-20Initiated

TerminatedStatus

AVKARE Inc.Firm

Product

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

Labeling: Label Error on Declared Strength

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.