FDA Recall D-0609-2024
Homeocare Laboratories, Inc. · Yonkers, NY
Class I — life-threatening Terminated 161 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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
Reason for recall
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Recall record
- Recall number
D-0609-2024- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide to 60 Physician offices
- Recall initiated
- 2024-06-05
- Classified by FDA Center
- 2024-07-17
- FDA published
- 2024-07-24
- Terminated
- 2024-11-13
- Recalling firm
- Homeocare Laboratories, Inc.
- Firm location
- Yonkers, NY
Drug identification
- Brand name(s)
- STELLALIFE VEGA ORAL CARE
- Generic name(s)
- ARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIA
- Manufacturer(s)
- StellaLife, Inc.
- NDC(s)
69685-121- Route(s)
- ORAL