Drug 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
D-1573-2014
Product summary
- Event
- Event 69141
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8-ct. 7,066 cases; 24-ct. 2,664 cases
- Official record key
drug-enforcement:D-1573-2014
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Code information: Lot: 44385; Exp.06/16; Lot: 44669; Exp.12/15
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination