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HomeoCare Laboratories Inc. Issues Recall of Stella Life Oral Care Spray Unflavored and Advanced Formula Peppermint Oral Care Rinse Due to Microbial Contamination

June 6, 2024

Audience: Consumers

Yonkers, NY, 06/05/2024 – HomeoCare Laboratories Inc., a manufacturer of homeopathic products, is voluntarily recalling two batches of Homeopathic StellaLife Oral Care Products listed in the table below manufactured in 2024 due to FDA findings of microbial contamination. This recall is to be performed at the consumer level.

Risk Statement: The following two (2) products listed below were found to contain higher than acceptable levels of TAMC (found in the StellaLife Advanced Formula Peppermint Vega Oral Care Rinse) and Bacillus sp (found in the StellaLife Vega Oral Spray, Unflavored).

While Bacillus is a common species found in the environment and are generally non-pathogenic, we understand 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.

It is important to note that no adverse events related to these two (2) products have been reported to HomeoCare to date.

We take these findings seriously and are taking immediate action to address the situation. We have initiated a voluntary recall of the two (2) affected batches listed below and are implementing enhanced quality control measures to prevent recurrence. Our priority remains the safety and well-being of our consumers, and we are committed to transparency and accountability throughout this process.

These Homeopathic products are marketed to promote oral health, hydrate oral cavities and support healthy gums. The affected products were manufactured at HomeoCare Laboratories, shipped nationwide to our customers, and distributed through various dental practices. The recall includes the following products and lot numbers:

Production Date

Release Date

Customers

Product Name

NDC

Lot No.

Expiration Date

02/16/2024 03/28/2024 StellaLife Inc. StellaLife VEGA Oral Care, Spray Unflavored 69685-121-01 2552 02-2026
03/01/2024 03/28/2024 StellaLife Inc. StellaLife Advanced Formula Peppermint VEGA Oral Care Rinse 69685-143-16 2550 02-2026

Dental practices who have the recalled products should examine their inventory and cease dispensing and return any of the impacted lots to HomeoCare Laboratories.

Consumers that have products which are being recalled should stop using the products and return them to place of purchase or discard them. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to using these products.

Consumers with questions regarding this recall can contact:

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

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