FDA recall D-1519-2016

Product

Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.

Reason for recall

Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-08-19

Report date

2016-10-05

Termination date

2017-02-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hasbrouck Heights, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1519-2016