Recalls / Class II

Class IID-0230-2017

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) 3-count disposable barrier cloths per package, 50 packages per carton, 2 cartons (100 packages) per case, Reorder # 7502, NDC 53462-915-51; d) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7508, NDC 53462-915-81; e) 24-count disposable barrier cloths per tub, 12 packages per case, Reorder # 7524, NDC 53462-915-60; f) 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) 45489, Exp. 8/23/2016; 45537, Exp. 8/25/2016; 45631, Exp. 9/1/2016; 45781, Exp. 9/10/2016; 46345, Exp. 10/18/2016; 46708, Exp. 11/9/2016; 46763, Exp. 11/11/2016; 47378, Exp. 1/5/2017; 47723, Exp. 1/27/2017; 48347, Exp. 3/4/2017; 49057, Exp. 4/18/2017; 49498, Exp. 5/16/2017; 49576, Exp. 5/19/2017; 49869, Exp. 6/8/2017; 51306, Exp. 9/10/2017; 51309, Exp. 9/10/2017; 51720, Exp. 10/6/2017; 52187, Exp. 11/7/2017; 52216, Exp. 11/8/2017; 52226, Exp. 11/8/2017; 52235, Exp. 11/9/2017; 52239, Exp. 11/9/2017; 52415, Exp. 11/19/2017; 52694, Exp. 12/8/2017; 52702, Exp. 12/8/2017; 52711, Exp. 12/9/2017; 52722, Exp. 12/9/2017; 52968, Exp. 1/4/2018; 53000, Exp. 1/5/2018; 54543, Exp. 4/10/2018; 54597, Exp. 4/12/2018; 55814, Exp. 6/20/18; b) 45408, Exp. 8/17/2016; 45427, Exp. 8/18/2016; 45451, Exp. 8/19/2016; 45468, Exp. 8/20/2016; 45483, Exp. 8/21/2016; 45557, Exp. 8/26/2016; 45650, Exp. 9/2/2016; 45768, Exp. 9/9/2016; 45893, Exp. 9/17/2016; 45998, Exp. 9/23/2016; 46169, Exp. 10/5/2016; 46432, Exp. 10/22/2016; 46512, Exp. 10/27/16; 46551, Exp. 10/29/16; 46608, Exp. 11/2/16; 46647, Exp. 11/4/2016; 46669, Exp. 11/6/2016; 46841, Exp. 11/17/2016; 46851, Exp. 11/17/2016; 46970, Exp. 11/29/2016; 47058, Exp. 12/2/2016; 47115, Exp. 12/7/2016; 47202, Exp. 12/14/2016; 47309, Exp. 12/20/2016; 47420, Exp. 1/8/2017; 47436, Exp. 1/10/2017; 47512, Exp. 1/13/2017; 47560, Exp. 1/17/2017; 47800, Exp. 2/2/2017; 47837, Exp. 2/3/2017; 48134, Exp. 2/19/2017; 48154, Exp. 2/21/2017; 48928, Exp. 4/9/2017; 48943, Exp. 4/11/2017; 49149, Exp. 4/25/2017; 49222, Exp. 4/29/2017; 49386, Exp. 5/9/2017; 49466, Exp. 5/12/2017; 49600, Exp. 5/20/2017; 49926, Exp. 6/13/2017; 50578, Exp. 7/27/2017; 50585, Exp. 7/27/2017; 50596, Exp. 7/28/2017; 50600, Exp. 7/28/2017; 50910, Exp. 8/15/2017; 51204, Exp. 9/6/2017; 51260, Exp. 9/8/2017; 51268, Exp. 9/8/2017; 51293, Exp. 9/9/2017; 51344, Exp. 9/13/2017; 51438, Exp. 9/19/2017; 51522, Exp. 9/23/2017; 51527, Exp. 9/23/2017; 51531, Exp. 9/23/2017; 51755, Exp. 10/7/2017; 51824, Exp. 10/13/2017; 52016, Exp. 10/26/2017; 52079, Exp. 10/29/2017; 52083, Exp. 10/31/2017; 52263, Exp. 11/10/2017; 52308, Exp. 11/14/2017; 52397, Exp. 11/18/2017; 52407, Exp. 11/18/2017; 52538, Exp. 11/29/2017; 52614, Exp. 12/5/2017; 52615, Exp. 12/5/2017; 52644, Exp. 12/6/2017; 52659, Exp. 12/6/2017; 52661, Exp. 12/7/2017; 52676, Exp. 12/7/2017; 52737, Exp. 12/12/2017; 52946, Exp. 1/3/2018; 53359, Exp. 1/25/2018; 53624, Exp. 2/14/2018; 53724, Exp. 2/20/2018; 53849, Exp. 2/27/2018; 53850, Exp. 2/27/2018; 54498, Exp. 4/6/2018; 54544, Exp. 4/10/2018; 54653, Exp. 4/17/2018; 54693, Exp. 4/18/2018; 54734, Exp. 4/20/2018; 54771, Exp. 4/24/2018; 54856, Exp. 4/28/2018; 54945, Exp. 5/4/2018; 55365, Exp. 5/30/2018; 55629, Exp. 6/12/2018; 56255, Exp. 7/18/2018; 56263, Exp. 7/19/2018; 56273, Exp. 7/19/2018; 56353, Exp. 7/24/2018; 56410, Exp. 7/27/18; 56413, Exp. 7/27/18; 56532, Exp. 8/3/18; c) 46225, Exp. 10/8/2016; 46554, Exp. 10/29/2016; 46915, Exp. 11/22/2016; 49296, Exp. 5/3/2017; 49343, Exp. 5/5/2017; 50105, Exp. 6/23/17; 50626, Exp. 7/30/2017; 50634, Exp. 7/30/2017; 50639, Exp. 7/30/2017; 51310, Exp. 9/12/2017; 51313, Exp. 9/12/2017; 51340, Exp. 9/13/2017; 52388, Exp. 11/17/2017; 52395, Exp. 11/18/2017; 52403, Exp. 11/18/2017; 52421, Exp. 11/19/2017; 52912, Exp. 12/21/2017; 52915, Exp. 12/22/2017; 52918, Exp. 12/22/2017; 53508, Exp. 2/6/2018; 54815, Exp. 4/26/2018; 56307, Exp. 7/20/2018; 56311, Exp. 7/21/2018; 56316, Exp. 7/21/2018; 56457, Exp. 7/29/2018; 56561, Exp. 8/4/18; d) 53304, Exp. 1/23/2018; 53339, Exp. 1/24/2018; 53342, Exp. 1/24/2018; 53357, Exp. 1/25/2018; 55784, Exp. 6/19/2018; e) 50806, Exp. 2/7/2017; 52305, Exp. 5/15/2017; f) 48066, Exp. 8/18/2016; 48110, Exp. 8/20/2016; 48596, Exp. 9/20/2016; 48668, Exp. 9/23/2016; 49249, Exp. 11/1/2016; 49335, Exp. 11/4/2016; 49535, Exp. 11/16/2016; 50614, Exp. 1/28/2017; 50702, Exp. 2/2/2017; 50988, Exp. 2/21/2017; 51288, Exp. 3/11/2017; 51715, Exp. 4/6/2017; 51745, Exp. 4/8/2017; 51749, Exp. 4/8/2017; 51754, Exp. 4/8/2017; 51765, Exp. 4/9/2017; 51870, Exp. 4/18/2017; 52484, Exp. 5/26/2017; 52864, Exp. 6/20/2017; 53398, Exp. 8/1/2017; 54081, Exp. 9/12/2017; 54373, Exp. 9/29/2017; 55537, Exp. 12/7/2017; 56020, Exp. 1/4/2018; 56107, Exp. 1/9/2018

Why it was recalled

CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.

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: 616,561 cases total
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-0230-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.