Drug recall D-1573-2014

Class II Terminated reported Sep 10, 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.

Lots and codes

Lot: 44385; Exp.06/16; Lot: 44669; Exp.12/15

Recall details

Recalling firm
Sage Products Inc, Cary, IL
Quantity
8-ct. 7,066 cases; 24-ct. 2,664 cases
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
August 27, 2014
Terminated
February 8, 2016

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