Recalls / Class II
Class IID-0610-2024
Product
STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-143-16
- Brand name
- Stellalife Vega Oral Care Peppermint
- Generic name
- Azadirachta Indica, Calendula, Echinacea Purpurea, Plantago Major
- Active ingredients
- Azadirachta Indica Bark, Calendula Officinalis Flower, Echinacea Purpurea, Plantago Major
- Route
- Oral
- NDC
- 69685-143
- Affected lot / code info
- Lot # 2550, exp. date 02-28-2026
Why it was recalled
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
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
- 31,110 x 16 fl. oz. 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-0610-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.