KEY POINTS

  • Lohxa, LLC's Chlorhexidine Gluconate Oral Rinse was distributed nationwide
  • The said product was sourced from Sunstar Americas Inc.
  • Sunstar Americas informed Lohxa about the probable contamination
  • People who have the product are being advised to stop using it immediately

Lohxa, LLC is recalling its Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol-free, 15 mL (NDC:70166-027-15) over possible contamination with the Burkholderia lata (B. lata) bacteria that is known for causing respiratory and other infections in patients with underlying illnesses.

In the company announcement posted on the Food and Drug Administration's (FDA) website on Monday, Lohxa noted that the affected products were sourced and repackaged from Sunstar Americas Inc., which notified the company about the possible contamination. Sunstar Americas Inc. also announced its own oral rinse recall on Oct. 27.

Although no adverse reactions have been reported as of the Monday company announcement, people who are immunocompromised may experience systemic infections that may require antibacterial therapy if they use the "defective products," the company explained in the announcement.

"In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia," the company said.

As such, anyone who has the affected products should stop using them immediately.

Sold as a prescription oral treatment for gingivitis, the affected products were distributed to hospital pharmacies nationwide. They have an expiration date from 1/31/21 to 3/31/21, and were packaged in cases that each contain 50 unit dose cups.

Specific Lot numbers and expiry dates of the affected products are as follows:

  • LOT T09101A - EXP 01/2021
  • LOT T08292A - EXP 02/2021
  • LOT T10011A - EXP 02/2021
  • LOT M10193A - EXP 03/2021
  • LOT T10223A - EXP 03/2021

Photos of the oral rinse being recalled are available at the company's announcement on the FDA website.

Anyone who experiences any adverse reactions related to the use of the product is being advised to contact their healthcare provider and report it to the FDA. Those with questions about the recall may contact Lohxa, LCC by sending an email to info@lohxa.com or calling 1-800-641-5564.

The company is also working to notify its customers by contacting them by mail and email to have the affected products returned.

"Lohxa, LLC is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue," Lohxa said in the company announcement.

FDA Food and Drug The FDA's headquarters and home of the Center for Drug Evaluation and Research in Silver Spring, Maryland. Photo: Wikipedia