Recalls / Class II
Class IID-0887-2023
Product
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16
- Brand name
- Stellalife Vega Oral Care Coconut
- Generic name
- Risne
- Active ingredients
- Apis Mellifera, Azadirachta Indica Bark, Calendula Officinalis Flower, Echinacea Purpurea, Okoubaka Aubrevillei Bark, Phosphorus, Plantago Major, Strontium, Thuja Occidentalis Leafy Twig
- Route
- Dental
- NDC
- 69685-113
- Affected lot / code info
- Lot # 2396, exp. date Apr-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
- 16,587 bottles
- 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-0887-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.