Why it was recalled
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Product description
Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040
Lot numbers, UPCs & expiration codes
Lot #: a) EK8760, Exp 2/17; EL1115, Exp 3/17; EL2358, Exp 4/17; EL6143, Exp 7/17; EM0837, Exp 10/17; EM2088, 12/17; A20899, Exp 5/18; A24492, Exp 6/18; b) EK8764, Exp 2/17; EL6145, Exp 7/17; EM2091, Exp 2/17; A25206, Exp 6/18.
Where it was sold
U.S. Nationwide
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-0510-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 19, 2017
- FDA report date
- Mar 15, 2017
- Quantity
- 272,062 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LEO PHARMA INC
Original FDA data
Every field from FDA enforcement report D-0510-2017, exactly as published.
Show all FDA fields
- City
- Madison
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76467
- Address
- 7 Giralda Farms
- Code information
- Lot #: a) EK8760, Exp 2/17; EL1115, Exp 3/17; EL2358, Exp 4/17; EL6143, Exp 7/17; EM0837, Exp 10/17; EM2088, 12/17; A20899, Exp 5/18; A24492, Exp 6/18; b) EK8764, Exp 2/17; EL6145, Exp 7/17; EM2091, Exp 2/17; A25206, Exp 6/18.
- Postal code
- 07940-1051
- Report date
- Mar 15, 2017
- Product type
- Drugs
- Recall number
- D-0510-2017
- Classification
- Class II
- Recalling firm
- LEO PHARMA INC
- Product quantity
- 272,062 tubes
- Termination date
- Jan 24, 2018
- Reason for recall
- Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Jan 19, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 3, 2017