PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: October 5, 2016 Initiated: August 19, 2016 #D-1519-2016

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.

Details

Units Affected
368 bottles
Distribution
Nationwide
Location
Hasbrouck Heights, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Unichem Pharmaceuticals Usa Inc. Units affected: 368 bottles.
Why was this product recalled?
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 5, 2016. Severity: Low. Recall number: D-1519-2016.