D-1519-2016 Class III Terminated

Recalled by Unichem Pharmaceuticals Usa Inc — Hasbrouck Heights, NJ

Recall Details

Product Type
Drugs
Report Date
October 5, 2016
Initiation Date
August 19, 2016
Termination Date
February 7, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
368 bottles

Product Description

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 Pattern

Nationwide

Code Information

Lot #: GLEH 16003, Exp 03/31/18