Recall: D-1519-2016

Class III - Minor Violations

Class IIIClassification

2016-08-19Initiated

TerminatedStatus

Unichem Pharmaceuticals Usa InFirm

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.