D-0510-2017 Class II Terminated
FDA drug recall D-0510-2017 was initiated by LEO PHARMA INC on Jan 19, 2017 and is designated Class II. 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… The recall status is terminated (terminated Jan 24, 2018). Affected quantity: 272,062 tubes.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 15, 2017
- Initiation Date
- Jan 19, 2017
- Termination Date
- Jan 24, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 272,062 tubes
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
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.
Distribution pattern
U.S. Nationwide
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0510-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026