Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013

Recall Number: D-1573-2014

Firm: Sage Products Inc

Classification: Class II

Status: Terminated

Report Date: 20140910

Initiation Date: 20140827

Termination Date: 20160208

Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.

Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013