Drug product
ORIS (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 D00513003001O
D-0874-2016
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 73491
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33,862 mL
- Official record key
drug-enforcement:D-0874-2016
Official wording
Reason: Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Code information: Lot # 628146, Exp 6/16; 629690, Exp 9/16; 348295, Exp 10/17
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out-of-specification