FDA recall D-0477-2017

Product

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.

Reason for recall

Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.

Distribution

Nationwide within US

Key facts

Status

Terminated

Initiation date

2017-01-16

Report date

2017-02-22

Termination date

2017-12-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Madison, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0477-2017