FDA recall D-1329-2022

AVKARE Inc. · Class III · drug

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 for recall

Labeling: Label Error on Declared Strength

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2022-07-20
Report date: 2022-08-17
Termination date: 2024-09-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1329-2022