Drug product
PerioRx (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 91701
D-0876-2016
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 73491
- Status
- Terminated
- Classification
- Class II
- Quantity
- 294,090 mL
- Official record key
drug-enforcement:D-0876-2016
Official wording
Reason: Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Code information: Lot # 627525, Exp 5/16; 628362, Exp 6/16; 628595, Exp 7/16; 629319, Exp 8/16; 629885, Exp 9/16; 630467,Exp10/16; 32218, 632500, Exp 2/17; 633075, 632799, Exp 3/17; 345624, 345679, Exp 5/17; 347420, 347662, Exp 9/17
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out-of-specification