FDA recall D-0231-2017

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.

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.

Key facts

Status

Terminated

Initiation date

2016-07-29

Report date

2016-12-28

Termination date

2019-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cary, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0231-2017