D-0477-2017 Class III Terminated
FDA drug recall D-0477-2017 was initiated by LEO PHARMA INC on Jan 16, 2017 and is designated Class III. Reason for recall: Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014. The recall status is terminated (terminated Dec 12, 2017). Affected quantity: 189,610 units.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 22, 2017
- Initiation Date
- Jan 16, 2017
- Termination Date
- Dec 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 189,610 units
Product description
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Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Distribution pattern
Nationwide within US
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0477-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026