Recalls / Class I
Class ID-0229-2017
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.
- Brand name
- Comfort Shield Barrier
- Generic name
- Dimethicone
- Active ingredient
- Dimethicone
- Route
- Topical
- NDC
- 53462-915
- FDA application
- M016
- Affected lot / code info
- 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
Why it was recalled
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Recalling firm
- Firm
- Sage Products LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3909 3 Oaks Rd, N/A, Cary, Illinois 60013-1804
Distribution
- Quantity
- 576,802 cases total for product codes 7503, 7905, and 7526
- 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.
Timeline
- Recall initiated
- 2016-07-29
- FDA classified
- 2016-12-22
- Posted by FDA
- 2016-12-28
- Terminated
- 2019-03-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0229-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.