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Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide within US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0477-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 16, 2017
- FDA report date
- Feb 22, 2017
- Quantity
- 189,610 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LEO PHARMA INC
Original FDA data
Every field from FDA enforcement report D-0477-2017, exactly as published.
Show all FDA fields
- City
- Madison
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76370
- Address
- 7 Giralda Farms
- 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.
- Postal code
- 07940-1051
- Report date
- Feb 22, 2017
- Product type
- Drugs
- Recall number
- D-0477-2017
- Classification
- Class III
- Recalling firm
- LEO PHARMA INC
- Product quantity
- 189,610 units
- Termination date
- Dec 12, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide within US
- Recall initiation date
- Jan 16, 2017
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Feb 15, 2017