Recalls / Class II
Class IID-0886-2023
Product
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16
- Brand name
- Stellalife Vega Oral Care Rinse
- Generic name
- Rinse
- Active ingredients
- Azadirachta Indica Bark, Calendula Officinalis Flower, Echinacea Purpurea, Plantago Major
- Route
- Dental
- NDC
- 69685-103
- Affected lot / code info
- Lot # 2357B,2333, exp. date Sep-2; 2367C, 2367D, exp. date Nov-23; 2367E, 2367F, exp. date Jan-24; 2395A, 2406, exp. date Feb-2; 2395B, exp. date Mar-24; 2395C, 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
- 130,762/16 oz. tottles
- 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-0886-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.