Recalls / Class II
Class IID-0890-2023
Product
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01
- Brand name
- Stellalife Vega Oral Care
- Generic name
- Spray
- 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
- Dental, Sublingual
- NDCs
- 69685-111, 69685-112, 69685-115
- Affected lot / code info
- Lot #2407, exp. date Feb-24; 2409A, exp. date Apr-24; 2409B, exp. date May-24
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- Homeocare Laboratories, Inc.
- Manufacturer
- StellaLife, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7 Odell Plz Ste 142-146, N/A, Yonkers, New York 10701-1407
Distribution
- Quantity
- 33,109/1 fl. oz. tubes
- Distribution pattern
- Product was distributed USA nationwide.
Timeline
- Recall initiated
- 2023-06-05
- FDA classified
- 2023-06-26
- Posted by FDA
- 2023-07-05
- Terminated
- 2024-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0890-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.