Reported Feb 22, 2017 · Terminated
Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC…
Leo Pharma Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LEO PHARMA INC · 7 Giralda Farms · Madison, NJ · 07940-1051
Is this the product you have?
- 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 Ltd285 Cashel RoadDublin 12 Ireland
- Distributed by
LEO Pharma Inc. 1 Sylvan WayParsippanyNJ 07054
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 (a): EK9025, Exp. 2/28/2017 2 EL1057, Exp. 3/31/2017 3 EL4637, Exp. 6/30/2017 4 EM0825B, Exp. 11/30/2017 5 EM3992, Exp. 1/31/2019 6 A22902, Exp. 5/31/2019 7 A31838, Exp. 9/30/2019 Lot #:EK7007A, EK7007AA, Exp. 1/31/2017 8 EL2024, EL2979, Exp. 5/31/2017 9 EL8069, Exp. 10/31/2017 10 EA20780AA, Exp. 5/31/2019. - Amount recalled
- 189,610 units
Where it was sold
- Nationwide
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Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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