Unichem Pharmaceuticals Usa Inc recalls Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pi…

Recall date

August 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1519-2016

FDA classification

Class III

Brand / firm

Unichem Pharmaceuticals Usa Inc

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What 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.