FDA Drug Recalls

Recalls / Class III

Class IIID-0950-2016

Product

¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-5205-5.

Affected lot / code info
Lot # A5192-18338, Expiry: 12/2016

Why it was recalled

Subpotent Drug

Recalling firm

Firm
Taro Pharmaceuticals U.S.A., Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
3 Skyline Dr, N/A, Hawthorne, New York 10532-2174

Distribution

Quantity
62,800 Tubes
Distribution pattern
U.S. Including: CA, CT, MA, MD, NY, NJ, OK, TX, and WA

Timeline

Recall initiated
2016-03-31
FDA classified
2016-05-31
Posted by FDA
2016-06-08
Terminated
2018-06-06
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0950-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.