Homeopathic products manufacturer HomeoCare Laboratories Inc. is recalling some of its oral care products due to microbial contamination that could potentially lead to fatal outcomes in individuals with oral diseases or compromised immune systems.
The U.S. Food and Drug Administration (FDA) announced the New York-headquartered company’s recall, which is being performed at the consumer level, in a June 5 notice.
According to the FDA notice, two batches of Homeopathic StellaLife Oral Care Products, both manufactured in 2024, are affected by the notice: StellaLife Advanced Formula Peppermint Vega Oral Care Rinse and StellaLife Vega Oral Spray, Unflavored.
The StellaLife Advanced Formula Peppermint Vega Oral Care Rinse has a lot number of 2550, a national drug code (NDC) of 69685-143-16, and an expiration date of 02-2026.
The StellaLife Vega Oral Spray, Unflavored has a lot number of 2552, an NDC of 69685-121-01, and an expiration date of 02-2026.
Both items, which are marketed on HomeoCare’s official website as promoting oral health, hydrating oral cavities, and supporting healthy gums, were manufactured at HomeoCare Laboratories and shipped throughout the United States to customers.
They were also distributed through various dental practices, the company said.
No Adverse Events Reported
The notice states that StellaLife Advanced Formula Peppermint Vega Oral Care Rinse was found to contain higher than acceptable levels of total aerobic microbial count (TAMC) and Bacillus sp, which was found in the StellaLife Vega Oral Spray, Unflavored.
HomeoCare Laboratories said that it “understands the concerns regarding potential risks, especially among patients with oral disease, undergoing dental surgical procedures or with compromised immune systems.”
“In the immunocompromised population, there is a risk that use of the product could result in severe or life-threatening adverse events due to the introduction of bacteria to the disrupted oral mucosa, possibly leading to bacteremia and sepsis,” the company added.
However, no adverse events have been reported to HomeoCare to date, according to the notice.
Dental practices that have the recalled products are being urged by the FDA to examine their inventory, stop dispensing the items, and return them to HomeoCare Laboratories.
Consumers who have the items are being asked to stop using them and to return them or discard them.
Individuals who are experiencing any problems that may be related to the impacted products are being urged to contact their physician or healthcare provider.
Adverse reactions can also be reported to the FDA’s MedWatch Adverse Event Reporting program either online or by mail or fax.
According to its official website, HomeoCare uses “original formulations taken from European Homeopathic Masters” to create “remedies for just about every ailment that are safer, non-interacting, and as powerful as their pharmaceutical counterparts.”
The company said that it uses “only the finest all-natural ingredients to produce safe, effective products that will enhance your life in so many different ways.”
It also has an FDA-registered Homeopathic laboratory, according to the website.
HomeoCare noted in the June 5 recall notice that it is also implementing “enhanced quality control measures” to prevent future microbial contaminations.
“Our priority remains the safety and well-being of our consumers, and we are committed to transparency and accountability throughout this process,” the company said.
From The Epoch Times