FDA-Drug2017-03-15Class II
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
LEO PHARMA INC
Hazard
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.
Sold states
U.S. Nationwide
Affected count
272,062 tubes
Manufactured in
7 Giralda Farms, N/A, Madison, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0510-2017Don't want to check this manually?
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