Calcipotriene Cream 0 recalled over undeclared excipients

Recall date

January 19, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

LEO PHARMA INC recalls Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Man…

Recall number

D-0510-2017

FDA classification

Class II

Brand / firm

LEO PHARMA INC

Sold / distributed

U.S. Nationwide

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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