Recall: D-0510-2017

Class II - Potentially Harmful

Class IIClassification

2017-01-19Initiated

TerminatedStatus

LEO PHARMA INCFirm

Product

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

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

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.