FDA Recall D-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.

Lot / code: 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

Quantity: 576,802 cases total for product codes 7503, 7905, and 7526

Reason for recall

Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.

Recall record

Recall number

D-0229-2017

Classification

Class I

Status

Terminated

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Letter

Distribution

Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.

Recall initiated

2016-07-29

Classified by FDA Center

2016-12-22

FDA published

2016-12-28

Terminated

2019-03-11

Recalling firm

Sage Products LLC

Firm location

Cary, IL

Drug identification

Brand name(s)

COMFORT SHIELD BARRIER

Generic name(s)

DIMETHICONE

Manufacturer(s)

Sage Products LLC

NDC(s)

53462-915

Route(s)

TOPICAL