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Reason: Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.

Code information: Lot #: a) 63800090, Exp 04/17; 63800095, Exp 11/17; 1000573, Exp 02/18; 1002560, Exp 06/18; b) 63800090, Exp 04/17; 63800092, Exp 07/17; 63800093, Exp 08/17; 63800095, Exp 11/17; 1000574, Exp 02/18; 1001772, Exp 05/18; c) 63800089, Exp 03/17; 63800091, Exp 07/17; 63800094, Exp 08/17; 1000842, Exp 01/18; 1000966, Exp 03/18; 1001771, Exp 05/18; 1002562, Exp 06/18.

Distribution pattern: Nationwide in the USA and Puerto Rico