HomeoCare Laboratories, a renowned manufacturer of homeopathic products, announced the recall of two batches of Homeopathic StellaLife Oral Care Products manufactured in 2024. The recall was prompted by the FDA's discovery of microbial contamination, posing potential health risks to consumers. The affected products, including StellaLife VEGA Oral Care Spray Unflavored and StellaLife Advanced Formula Peppermint VEGA Oral Care Rinse, were found to contain higher than acceptable levels of TAMC and Bacillus sp.
While Bacillus is commonly found in the environment and is usually non-pathogenic, the presence of elevated levels in oral care products raises concerns, especially for individuals with oral diseases or compromised immune systems. In immunocompromised individuals, the use of contaminated products could lead to severe adverse events, such as bacteremia and sepsis, by introducing bacteria to disrupted oral mucosa. Despite no reported adverse events related to the products, HomeoCare Laboratories is taking proactive measures to ensure consumer safety.
The voluntary recall aims to address the potential risks associated with microbial contamination and prevent any adverse effects on consumers. HomeoCare Laboratories is committed to transparency and accountability throughout the recall process, prioritizing the safety and well-being of its customers. The affected products, designed to promote oral health and support healthy gums, were distributed nationwide through various dental practices, emphasizing the importance of immediate action to mitigate potential health hazards.
Healthcare providers and consumers are advised to discontinue the use of the recalled products and return them to the place of purchase or discard them. Dental practices that possess the affected batches should cease dispensing and return them to HomeoCare Laboratories. Consumers experiencing any issues related to the use of the products are encouraged to contact their physician or healthcare provider. Furthermore, questions regarding the recall can be directed to HomeoCare Inc. and StellaLife through the provided contact information.
The recall underscores the critical importance of stringent quality control measures in the manufacturing of healthcare products to ensure consumer safety and well-being. By promptly addressing the issue of microbial contamination and initiating a recall, HomeoCare Laboratories demonstrates its commitment to maintaining high standards of product quality and protecting the health of its consumers.
