PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: December 28, 2016 Initiated: July 29, 2016 #D-0231-2017

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Sage Products LLC
Units Affected
2756 cases
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.
Location
Cary, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Sage Products LLC. Units affected: 2756 cases.
Why was this product recalled?
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 28, 2016. Severity: Moderate. Recall number: D-0231-2017.