Paroex Chlorhexidine Gluconate Oral Rinse Recall

FDA issues recall alert on prescription oral rinse due to possible contamination

Oral rinse recall

According to an online news report posted on cda.org, Sunstar Americas, Inc. initiated a safety recall regarding its prescription Paroex Chlorhexidine Gluconate Oral Rinse, 0.12% mouthwash due to possible Burkholderia lata microbial contamination.

The U.S. Food and Drug Administration news release states that Sunstar America’s Paroex Chlorhexidine Gluconate Oral Rinse, 0.12% mouthwash, might be contaminated with Burkholderia lata. Burkholderia lata is a bacterium that could cause a life-threatening infection, such as bacteremia and pneumonia in users.

Paroex Chlorhexidine Gluconate Oral Rinse, 0.12% mouthwash, is primarily used to treat patients suffering from gingivitis. The recalled product lists an expiration date starting on June 30, 2022, and ends with the date of September 30, 2022.

The affected Paroex Chlorhexidine Gluconate Oral Rinse, 0.12% mouthwash, was throughout North America to dental distributors, dental offices, dental schools, pharmaceutical wholesalers, and pharmacies.

1. 1789PGUM® Paroex® was distributed in cases, and each case contained six amber bottles of 16 fluid ounce (473 ml) chlorhexidine rinse. The amber bottles have a child-resistant cap and include a 15 ml dosage cup. The bottles are safety sealed and are covered with a multiple-panel label that wraps around the bottle.
2. 1788PGUM® Paroex® was distributed in cases of 24 amber bottles containing four fluid ounces (118.25 ml) of the chlorhexidine rinse. Each bottle has a child-resistant cap, is safety sealed, and is covered with a multiple-panel label that wraps around the bottle.

According to the safety recall notice provided by the FDA, Sunstar America is cautioning its customers and direct distributors by U.S. Postal Service priority mail and is organizing the return of the recalled mouthwash. Pharmacies, patients, dental clinics, and health care facilities that have the recalled products are asked to stop using and dispensing the recalled mouthwash immediately.

Currently, the FDA recall notice does not report any adverse events related to the oral rinse recall. Dentists and patients may with questions about the safety recall may contact Sunstar Americas, Inc. through their website or contact details on the company’s website, sunstar.com.

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