Recalls / Class I
Class ID-0609-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01
- Brand name
- Stellalife Vega Oral Care
- Generic name
- Arnica, Calendula, Chamomilla, Echinacea Angustifolia, Echinacea Purpurea, Hepar Sulph Calc, Hypericum, Lgnatia, Ruta, Staphysagria
- Active ingredients
- Arnica Montana, Calcium Sulfide, Calendula Officinalis Flowering Top, Delphinium Staphisagria Seed, Echinacea Angustifolia, Echinacea Purpurea, Hypericum Perforatum, Ledum Palustre Twig, Matricaria Recutita, Ruta Graveolens Flowering Top, Silicon Dioxide, Strychnos Ignatii Seed
- Route
- Oral
- NDC
- 69685-121
- Affected lot / code info
- Lot # 2552, exp. date 02-28-2026
Why it was recalled
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Recalling firm
- Firm
- Homeocare Laboratories, Inc.
- Manufacturer
- StellaLife, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 7 Odell Plz Ste 142-146, Yonkers, New York 10701-1407
Distribution
- Quantity
- 31,811 x 1 fl. oz. spray bottle
- Distribution pattern
- Nationwide to 60 Physician offices
Timeline
- Recall initiated
- 2024-06-05
- FDA classified
- 2024-07-17
- Posted by FDA
- 2024-07-24
- Terminated
- 2024-11-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0609-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.