Sunstar Americas is voluntarily recalling its Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products from specific lots bearing an expiration date from June 30, 2022, to September 30, 2022, to the consumer level. The product may be contaminated with the bacteria Burkholderia lata.
Use of the defective product in immunocompetent hosts 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 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. The impacted product, 1789C GUM Paroex UPC 0 70942 30407 8 is distributed in cases of six 16-fluid-ounce (473 ml) chlorhexidine rinse.
The bottle has a childproof cap and a 15-ml metered dosage cup. It is safety sealed and decorated with a multiple-panel wraparound label. Paroex was distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies.
Sunstar Americas is notifying its direct distributors and customers by Canada Post Express and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities that have these products should stop using and dispensing them immediately.
For more information, call (800) 265-8353, Monday through Friday from 8:30 am to 5 pm ET, or email can.customerrelations@ca.sunstar.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using the product.
The affected lot, Paroex 473ml (DIN 02384272)/ SKU 1789C / UPC 0 70942 30407 8, includes C177GS (expiration date July 31, 2022), C177GT (expiration date July 31, 2022), C177GU (expiration date July 31, 2022), C219DH (expiration date August 31, 2022), and C219DJ (expiration date August 31, 2022).
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