Sunstar Americas Inc. issues recall of chlorhexidine gluconate oral rinse USP, 0.12% due to microbial contamination

Sunstar Americas Inc. issues recall of chlorhexidine gluconate oral rinse USP, 0.12% due to microbial contamination

cbaker_admin
Fri, 10/30/2020 – 00:30

Sunstar Americas, Inc. (SAI) announced a voluntary, nationwide recall of certain chlorhexidine gluconate oral rinse (Paroex), USP, 0.12% products because they may be contaminated with Burkholderia lata bacteria. The prescription oral rinse product—distributed to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies—is indicated for use as part of a professional program for the treatment of gingivitis. To date, no adverse events have been reported to SAI related to this recall. The affected products carry an expiration date from June 30, 2022 through September 30, 2022. Additional details about the affected products and lots are available here.