6/5/24 Two dental products recalled: Homeopathic StellaLife Oral Care Spray Unflavored and Advanced Formula Peppermint Oral Care Rinse due to FDA findings of Microbial Contamination.
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.
While Bacillus is a common species found in the environment and are generally non-pathogenic, HomeoCare Laboratories Inc., a manufacturer of homeopathic products 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.
It is important to note that no adverse events related to these two (2) products have been reported to HomeoCare to date.
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 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.
ACTION
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.
CONTACT
Consumers with questions regarding this recall can contact:
HomeoCare Inc. by phone at (914) 920-5991 (09:00am-03:00pm EST Monday through Thursday)
HomeoCare Inc. by email address qualityassurance@homeocare.com
StellaLife by phone at (305) 788-8555
StellaLife by email at support@stellalife.com
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.
Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.