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Safety Report: StellaLife Inc. Homeopathic StellaLife Oral Care Products - recalled due to microbial contamination, USA

1 week ago •source fda.gov

Recall notice

StellaLife Inc. Homeopathic StellaLife Oral Care Products - recalled due to microbial contamination photo #1

United States

HomeoCare Laboratories Inc. is voluntarily recalling two batches of Homeopathic StellaLife Oral Care Products manufactured in 2024 due to FDA findings of microbial contamination. This recall is to be performed at the consumer level. The affected products were manufactured at HomeoCare Laboratories, shipped nationwide to our customers, and distributed through various dental practices.

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.

These Homeopathic products are marketed to promote oral health, hydrate oral cavities and support healthy gums. The recall includes the following products and lot numbers:
- Product Name: StellaLife VEGA Oral Care, Spray Unflavored, Production Date: 02/16/2024, Release Date: 03/28/2024, NDC: 69685-121-01, Lot No.: 2552, Expiration Date: 02-2026.
- Product Name: StellaLife Advanced Formula Peppermint VEGA Oral Care Rinse, Production Date: 03/01/2024, Release Date: 03/28/2024, NDC: 69685-143-16, Lot No.: 2550, Expiration Date: 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. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to using these products.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: HomeoCare Laboratories Inc.
Brand name: StellaLife Inc.
Product recalled: Homeopathic StellaLife Oral Care Products
Reason of the recall: Microbial contamination
FDA Recall date: June 05, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/homeocare-laboratories-inc-issues-voluntary-nationwide-recall-homeopathic-stella-life-oral-care

#drugs #recall #us

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