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, Dis

FDA recall notice · announced February 22, 2017 · Leo Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

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Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.

Notes

Distribution: Nationwide within US
Lot/code information: 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.
Quantity: 189,610 units
Status: Terminated
Products in this recall event:
- 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 Lab (D-0477-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.