FDA-Drug2016-12-28Class II
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.
Sage Products LLC
Hazard
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Sold states
Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
Affected count
2756 cases
Manufactured in
3909 3 Oaks Rd, N/A, Cary, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0231-2017Don't want to check this manually?
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