FDA Drug recall D-0876-2016
PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental,…
- FDA Drug
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental,… by Akorn, citing failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0876-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-23 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Akorn |
| Distribution | US |
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
Reason
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Identifiers
| upc | 423502091701 |
|---|---|
| code_info | 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,…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0876-2016%22
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