Homeopathic StellaLife Oral Care Products Recalled due to Microbial Contamination
HomeoCare Laboratories Inc., a manufacturer of homeopathic products, is recalling certain oral care products due to microbial contamination that could have fatal consequences for individuals with oral diseases or compromised immune systems. The U.S. Food and Drug Administration (FDA) announced the recall on June 5.
According to the FDA notice, two batches of Homeopathic StellaLife Oral Care Products, both manufactured in 2024, are affected by the recall. The products in question are the StellaLife Advanced Formula Peppermint Vega Oral Care Rinse and the 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. These products, which are marketed on HomeoCare’s official website as promoting oral health and supporting healthy gums, were manufactured at HomeoCare Laboratories and distributed throughout the United States.
The recall was initiated due to higher than acceptable levels of total aerobic microbial count (TAMC) and the presence of Bacillus sp. in the products. While no adverse events have been reported to HomeoCare thus far, there is a potential risk for severe or life-threatening adverse events in individuals with oral diseases or compromised immune systems. The introduction of bacteria to the disrupted oral mucosa could lead to bacteremia and sepsis.
The FDA is urging dental practices that have the recalled products to examine their inventory, cease dispensing the items, and return them to HomeoCare Laboratories. Consumers who have purchased the affected products are advised to discontinue use and either return them or discard them. Anyone experiencing issues related to the impacted products should contact their physician or healthcare provider.
HomeoCare Laboratories acknowledges the concerns regarding potential risks and has expressed its commitment to the safety and well-being of consumers. The company is implementing enhanced quality control measures to prevent future microbial contaminations. It also operates an FDA-registered Homeopathic laboratory.
In light of this recall, it is essential for consumers to be cautious when using homeopathic products. While homeopathy is a popular alternative medicine practice, it is crucial to note that there is limited scientific evidence to support its efficacy. Therefore, individuals with oral diseases or compromised immune systems should seek advice from healthcare professionals before using such products.
This recall serves as a reminder of the importance of regulatory oversight in ensuring the safety of consumer products. The FDA plays a crucial role in monitoring and addressing potential risks associated with various products on the market. Consumers should remain vigilant and report any adverse reactions to the FDA’s MedWatch Adverse Event Reporting program.
In conclusion, the recall of Homeopathic StellaLife Oral Care Products highlights the potential risks of microbial contamination in homeopathic products. It is crucial for individuals with oral diseases or compromised immune systems to exercise caution when using such products and consult healthcare professionals for guidance. The FDA’s role in overseeing product safety is vital, and consumers should report any adverse reactions to ensure ongoing monitoring and protection.
