LEO PHARMA INC recalls Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50…

Recall date

January 16, 2017

Source

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

Recall number

D-0477-2017

FDA classification

Class III

Brand / firm

LEO PHARMA INC

Sold / distributed

Nationwide within US

Why it was recalled

Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.

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

What was recalled

Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222-501-06), and (b)120 g (50222-501-66) tubes, Rx Only, Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12 Ireland, Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054.