Drug product
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.
D-0229-2017
Product summary
- Event
- Event 74819
- Status
- Terminated
- Classification
- Class I
- Quantity
- 576,802 cases total for product codes 7503, 7905, and 7526
- Official record key
drug-enforcement:D-0229-2017
Official wording
Reason: Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Code information: Lot #: a) 53957, Exp 03/06/18; b) 54769, Exp 04/22/18; 54922, Exp 05/03/18; 55781, Exp 06/19/18; c) 53095, Exp 07/13/17
Distribution pattern: Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
Derived failure modes
-
Microbial contamination
Microbial Contamination