FDA recall D-1573-2014

Product

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-08-27

Report date

2014-09-10

Termination date

2016-02-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cary, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1573-2014