D-0874-2016 Class II Terminated
FDA drug recall D-0874-2016 was initiated by Akorn, Inc. on Mar 23, 2016 and is designated Class II. Reason for recall: Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate. The recall status is terminated (terminated Nov 30, 2017). Affected quantity: 33,862 mL.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 1, 2016
- Initiation Date
- Mar 23, 2016
- Termination Date
- Nov 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,862 mL
Product Description
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
Reason for Recall
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot # 628146, Exp 6/16; 629690, Exp 9/16; 348295, Exp 10/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0874-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026