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
Reported: June 1, 2016 Initiated: March 23, 2016 #D-0876-2016
Product Description
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 for Recall
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 294,090 mL
- Distribution
- Nationwide and Puerto Rico
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Akorn, Inc.. Units affected: 294,090 mL.
Why was this product recalled? ▼
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 1, 2016. Severity: Moderate. Recall number: D-0876-2016.
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