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LEO PHARMA INC Recall: Taclonex (calcipotriene and betamethasone dipropionate) Topical Sus

LEO PHARMA INC Recall: Taclonex (calcipotriene and betamethasone dipropionate) Topical Sus is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: LEO PHARMA INC; Product: Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222

Recalling firmLEO PHARMA INC
ProductTaclonex (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Reason for recallLabeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
ClassificationClass III (least serious — unlikely to cause adverse health consequences)
StatusTerminated
DistributionNationwide within US
Recall initiated20170116
Recall numberD-0477-2017
Categorydrug
StateNJ
CountryUnited States

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