Product: Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080.
Reason for recall: Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Recall initiated: 20180119
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated