FDA-Drug2016-06-01Class II
PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701
Akorn, Inc.
Hazard
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Sold states
Nationwide and Puerto Rico
Affected count
294,090 mL
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0876-2016Don't want to check this manually?
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