Recalls / Class II
Class IID-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
- Brand name
- Comfort Shield Barrier
- Generic name
- Dimethicone
- Active ingredient
- Dimethicone
- Route
- Topical
- NDC
- 53462-915
- FDA application
- M016
- Affected lot / code info
- Lot: 44385; Exp.06/16; Lot: 44669; Exp.12/15
Why it was recalled
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Recalling firm
- Firm
- Sage Products Inc
- Manufacturer
- Sage Products LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3909 3 Oaks Rd, Cary, Illinois 60013-1804
Distribution
- Quantity
- 8-ct. 7,066 cases; 24-ct. 2,664 cases
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-08-27
- FDA classified
- 2014-09-03
- Posted by FDA
- 2014-09-10
- Terminated
- 2016-02-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1573-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.