FDA recall D-0510-2017

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 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

U.S. Nationwide

Key facts

Status

Terminated

Initiation date

2017-01-19

Report date

2017-03-15

Termination date

2018-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Madison, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0510-2017