PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 10, 2014 Initiated: August 27, 2014 #D-1573-2014

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Sage Products Inc
Units Affected
8-ct. 7,066 cases; 24-ct. 2,664 cases
Distribution
Nationwide
Location
Cary, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Sage Products Inc. Units affected: 8-ct. 7,066 cases; 24-ct. 2,664 cases.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 10, 2014. Severity: Moderate. Recall number: D-1573-2014.