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  3. Recall Enforcement Event ID: 73491

Recall Enforment Report D-0875-2016

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Akorn, Inc., originally initiated on 03-23-2016 for the 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 The product was recalled due to failed impurities/degradation specifications: out-of-specification result (for multiple batches) for an unknown impurity of chlorhexidine gluconate.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0875-201603-23-201606-01-2016Class II3,112,657 mLChlorhexidine 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 5083-0720-16Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.Terminated
D-0876-201603-23-201606-01-2016Class II294,090 mLPerioRx (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 91701Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.Terminated
D-0874-201603-23-201606-01-2016Class II33,862 mLORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001OFailed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.Terminated