FDA recall D-1289-2020

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 for recall

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

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2020-05-28

Report date

2020-06-10

Termination date

2021-10-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1289-2020