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

FDA recall notice · announced September 10, 2014 · Sage Products

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Lot: 44385; Exp.06/16; Lot: 44669; Exp.12/15
Quantity: 8-ct. 7,066 cases; 24-ct. 2,664 cases
Status: Terminated
Products in this recall event:
- 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 (D-1573-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.