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.
Check against the official notice below — it lists the full affected range.
Sage Products LLC is recalling 2% Chlorhexidine Gluconate Cloth products due to potential contamination from manufacturing equipment and production lines. The recall affects 2,756 cases of the product, which comes in packages of two disposable cloths. Three reorder numbers are involved: #9705, #9701-P, and #9780, with multiple lot numbers and expiration dates ranging from September 2016 through September 2017. The affected products were distributed nationwide and internationally to countries including Canada, Mexico, the United Kingdom, Germany, Australia, and several others in the Middle East and Europe.
Consumers who have purchased this product should identify whether they have one of the affected lot numbers listed in the recall notice. The record does not specify what actions affected consumers should take regarding their products.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Reason for recall: CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product. 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. Quantity: 2756 cases Lot/code info: 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.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.