Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific lots below) to the consumer level. This product may be contaminated with the bacteria Burkholderia lata.
Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to SAI related to this recall.
The prescription oral rinse product, available through healthcare professionals only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:
- 1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 ml) chlorhexidine rinse. The bottle has a childproof cap and a 15 ml metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
- 1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 ml) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.
The product can be identified by as shown in the images below:
Paroex was distributed Nationwide to Dental offices, Dental distributors, Pharmaceutical wholesalers, Dental schools, and Pharmacies.
SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.
Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email [email protected] on Monday-Friday from 8am-5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
Affected products and lot numbers follow below:
|Product name: Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% NDC # 052376-021-02 P/N 1789P 16 fl oz|
|Lot #||Exp Date||Lot #||Exp Date||Lot #||Exp Date|
|Product name: Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% NDC # 052376-021-04 P/N 1788P 4.0 fl oz|
|Lot #||Exp Date|