Akorn, Inc. recalls Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH
Recalled June 1, 2016 · FDA recall D-0875-2016 · Akorn
Hazard
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate. · FDA Class II
Units
3,112,657 mL
Sold at
Nationwide and Puerto Rico
Description
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Product
Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →