A bacteria that is known for causing respiratory infections as well as other kinds of infections in patients with underlying illnesses was recently found in an oral rinse.
There were already several times that issues of contamination were behind a product’s recall.
For instance, Zantac, a popular heartburn medication, was recalled by a number of American health agencies because it was found to be contaminated with “impurities.”
Only in this case, they were not just plain simple impurities, but they were dangerous levels of NDMA, which is a cancer-causing agent.
And even though contaminated batches were recalled by several health agencies in America and in Europe, it might already be too late for those people who have taken the medication over the course of several years.
This is why today, the Zantac lawsuits are seeing a growing number of plaintiffs who developed cancer after taking the medication for a couple of years and are now seeking justice against the manufacturer of the drug.
In this article, however, you are going to read about the recall of a product due to concerns of possible bacterial contamination.
Lohxa, LLC has voluntarily recalled its Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol-free, 15 mL (NDC:70166-027-15) due to possible contamination with the Burkholderia lata bacteria.
How It Could Affect Patients
According to the company announcement by Lohxa posted in the U.S. Food and Drug Administration’s website, the affected products were sourced and repackaged from SunStar Americas Inc., who has notified the company of the possible contamination.
Sunstar Americas Inc. also announced its own oral rinse recall ahead of Lohxa.
No reports of adverse events have been made when the company made the recall announcement.
However, use of the defective product in people who are immunocompromised may result in oral and potentially systemic infections that may require antibacterial therapy, the company explained through its announcement.
“In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia,” Lohxa, LLC added.
Affected Products
The oral rinse product is prescribed for the treatment of gingivitis and is available only for institutional use.
Chlorhexidine Gluconate Oral Rinse, USP, 0.12% Alcohol free was distributed to hospital pharmacies nationwide.
The impacted products bear expiration dates from 1/31/21 to 3/31/21 and were packaged in cases each containing 50 unit dose cups. Each case has a colored label around the lid and body of the case.
Here are the specific lot numbers and expiry dates of the recalled products:
- 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
What You Can Do
Lohxa, LLC has notified its customers by contacting them through email and mail to arrange for the return of the affected products.
Meanwhile, anyone who experiences adverse reactions or medical problems related to the use of the recalled product is advised to tell their healthcare provider and report these problems to the FDA’s MedWatch Adverse Event Reporting program.
