News

Article

Recall of Paroex Oral Rinse Expanded

Sunstar Americas is expanding its voluntary recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products because of Burkholderia lata contamination.

Sunstar Americas, Inc. (Schaumburg, IL) announced on Dec. 28, 2020 that it is expanding its recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products, with an expiration date from 12/31/2020–9/30/2022, because of Burkholderia lata contamination. The initial recall was announced on Oct. 27, 2020.

The company has received 29 reports of adverse events related to the recall, with patients testing positive for Burkholderia lata infections. The company cautions that use of the product, which is used treat gingivitis, is unsafe for patients with pre-existing respiratory conditions and “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.”

Adverse events may be reported to FDA through the agency’s MedWatch program. Information on the impacted lots may be found on FDA.gov.

Source: FDA

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
Related Content