Drug 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.
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
Related products
- Comfort Shield Barrier – drug information
- NDC 53462-915 Comfort Shield Barrier · Dimethicone 30 mg/g · Sage Products LLC