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 Plainfeld, NJ 07080.
Reason for recall: Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Recall initiated: 20170320
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated