Recall of Paroex Oral Rinse Expanded

December 31, 2020
Pharmaceutical Technology Editors

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