Recalls / Class III
Class IIID-0477-2017
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.
- Brand name
- Taclonex
- Generic name
- Calcipotriene And Betamethasone Dipropionate
- Active ingredients
- Betamethasone Dipropionate, Calcipotriene Hydrate
- Route
- Topical
- NDC
- 50222-501
- FDA application
- NDA022185
- Affected 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.
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Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Recalling firm
- Firm
- LEO PHARMA INC
- Manufacturer
- LEO Pharma Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 7 Giralda Farms, N/A, Madison, New Jersey 07940-1051
Distribution
- Quantity
- 189,610 units
- Distribution pattern
- Nationwide within US
Timeline
- Recall initiated
- 2017-01-16
- FDA classified
- 2017-02-15
- Posted by FDA
- 2017-02-22
- Terminated
- 2017-12-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0477-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.