Recall: D-1289-2020

Class III - Minor Violations

Class IIIClassification

2020-05-28Initiated

TerminatedStatus

AVKARE Inc.Firm

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. Pulaski, TN 38478.

Reason

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

Distribution

Nationwide in the U.S.

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