Sunstar Americas Expands Voluntary Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP

Sunstar Americas recently announced that it has expanded its voluntary recall to cover a larger batch of its Paroex® Chlorhexidine Gluconate Oral Rinse USP, 12% due to potential contamination with the bacteria Burkholderia lata.

The original recall was issued in October 2020, and it has now been expanded to include products bearing an expiration date from 12/2020 – 09/2022. The infected products could potentially lead to oral, or systemic infections that could become life-threatening.

To date, 29 adverse events related to this recall have been reported to Sunstar. Affected patients tested positive for Burkholderia lata infections. Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with coronavirus disease 2019, is particularly unsafe.

The specific product lines covered under this recall are:

• 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.

Sunstar is notifying its 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 immediately stop using or dispensing them.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email us.pcr@us.sunstar.com 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:

• Product name: Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%
  Size/ Form: 16 fl.oz. Amber Bottles
  Product Code: 1789P
  Lots Recalled: ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022
• Product name: Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%
  Size/ Form: 4 fl.oz. Amber Bottles
  Product Code: 1788P
  Lots Recalled: ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.