2% Chlorhexidine Gluconate* Cloth recalled over manufacturing violations

Recall date

July 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sage Products LLC recalls 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled…

Recall number

D-0231-2017

FDA classification

Class II

Brand / firm

Sage Products LLC

Sold / distributed

Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.