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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug

Sage Products LLC: Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.; CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.

Agency Publication Date: December 22, 2016
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Affected Products

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;

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

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;

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

Product: 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.

Lot #: a) 50749, Exp. 9/29/16; 50765, Exp. 9/30/16; 50771, Exp. 9/30/16; 50773, Exp. 10/01/16; 52839, Exp. 2/9/17; 52843, Exp. 2/9/17; 52855, Exp. 2/10/17; 52861, Exp. 2/10/17; 53840, Exp. 4/21/17; 56081, Exp. 9/1/17; 56513, Exp. 9/26/17; b) 54760, Exp. 6/15/17; c) 54763, Exp. 6/16/17 a) Lot # 50749 , Exp. 9/29/2016 ; Lot # 50765 , Exp. 9/30/2016 ; Lot # 50771 , Exp. 9/30/2016 ; Lot # 50773 , Exp. 10/1/2016 ; Lot # 52839 , Exp. 2/9/2017 ; Lot # 52843 , Exp. 2/9/2017 ; Lot # 52855 , Exp. 2/10/2017 ; Lot # 52861 , Exp. 2/10/2017 ; Lot # 53840 , Exp. 4/21/2017 . b) Lot # 54763, Exp. 6/16/2017. c) Lot # 54760, Exp. 6/15/2017.

Lot Numbers:
50749
50765
50771
50773
52839
52843
52855
52861
53840
54763
54760

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 74819
Status: Resolved
Manufacturer: Sage Products LLC
Manufactured In: United States
Units Affected: 3 products (576,802 cases total for product codes 7503, 7905, and 7526; 616,561 cases total; 2756 cases)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.