Multi-event July 2016 FDA Recall Chlorhexidine Gluconate by Sage Products Llc
This Multi-event Class I drug recall was voluntarily initiated by Sage Products Llc on July 29, 2016 for the product Chlorhexidine Gluconate. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0229-2017
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
07-29-2016
12-28-2016
576,802 cases total for product codes 7503, 7905, and 7526
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sage Products LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial 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.
03-11-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
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
Recall Number: D-0230-2017
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
07-29-2016
12-28-2016
616,561 cases total
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sage Products LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial 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.
03-11-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
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
Recall Number: D-0231-2017
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
07-29-2016
12-28-2016
2756 cases
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sage Products LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial 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.
03-11-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
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.
