LEO PHARMA INC: 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, Manufact

Is my product affected?

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, Pa

• Brand TACLONEX

Check against the official notice below — it lists the full affected range.

What happened

Leo Pharma Inc. is recalling Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, in 60-gram and 120-gram tubes nationwide. The recall affects 189,610 units across multiple lot numbers with expiration dates ranging from February 2017 through January 2019. The product was distributed with an out-of-date package insert dated February 2014 instead of the current package insert.

The recall document does not specify a remedy or action for affected consumers to take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.

Details from the source

Reason for recall: Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.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 Quantity: 189,610 units Lot/code info: Lot #: (a): EK9025, Exp. 2/28/2017; EL1057, Exp. 3/31/2017; EL4637, Exp. 6/30/2017; EM0825B, Exp. 11/30/2017; EM3992, Exp. 1/31/2019; A22902, Exp. 5/31/2019; A31838, Exp. 9/30/2019 Lot #:EK7007A, EK7007AA, Exp. 1/31/2017; EL2024, EL2979, Exp. 5/31/2017; EL8069, Exp. 10/31/2017; EA20780AA, Exp. 5/31/2019.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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