Recalls / Class II
Class IID-0874-2016
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
- Affected lot / code info
- Lot # 628146, Exp 6/16; 629690, Exp 9/16; 348295, Exp 10/17
Why it was recalled
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 33,862 mL
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-03-23
- FDA classified
- 2016-05-25
- Posted by FDA
- 2016-06-01
- Terminated
- 2017-11-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0874-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.