Safety Report: GUM Paroex Chlorhexidine Gluconate Oral Rinse - recalled due to potential contamination with Burkholderia lata, USA

United States

Company name: Precision Dose Inc.
Brand name: GUM Paroex
Product recalled: Paroex Chlorhexidine Gluconate Oral Rinse, 15 mL unit dose cups
Reason of the recall: Potential contamination with Burkholderia lata
FDA Recall date: December 31, 2020
Recall details: Company Announcement Precision Dose, Inc. is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing an expiration date from 1/31/2021 – 02/28/2022 (see specific lots below) to the consumer level. Precision Dose, Inc. was notified by the manufacturer of the product, Sunstar Americas, Inc., that this product may be contaminated with the bacteria Burkholderia lata.

From information provided by the manufacturer, Sunstar Americas, Inc., use of the defective product in the immunocompetent host 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 pneumonia and bacteremia.

To date, no adverse events have been reported to Precision Dose, Inc. 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 and the product impacted is:

- Distributed in cases each containing 3 shrink-wrapped plastic trays each with 10 unit dose cups, 30-pack. NDC 68094-028-62
- Distributed in cases each containing 10 shrink-wrapped plastic trays each with 10 unit dose cups, 100-pack. NDC 68094-028-61

Chlorhexidine Gluconate Oral Rinse was distributed nationwide in the USA to pharmaceutical wholesalers. Precision Dose, Inc. is notifying its consignees directly and is arranging for return of all recalled product. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact Precision Dose, Inc. at 1 (800) 397-9228 (Monday-Friday, 8:00 AM to 4:30 PM Central Time) or by email to customercare@precisiondose.com. Consumers should contact their physician or healthcare provider if they have experienced problems that may be related to using this drug product. Affected products and lot numbers follow below: AFFECTED LOTS-Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/precision-dose-inc-issues-voluntary-nationwide-recall-paroex-chlorhexidine-gluconate-oral-rinse-usp

Source: FDA