FDAFDA · Food and drugs·Recall number D-0477-2017
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.
Published February 22, 2017 · Recall initiated: January 16, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- TACLONEX
- Manufacturer
- LEO PHARMA INC
- Distributor
- Nationwide within US
- Lot
- 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.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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