Class II · Moderate risk
STELLALIFE ADVANCED FORMULA Peppermint
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
STELLALIFE VEGA Oral Care
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
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
Affected NDC
69685-0121-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| StellaLife VEGA Oral Care Pain and Swelling Relief Arnica, Calendula, Chamomilla, Echinacea angustifolia, Echinacea purpurea, Hepar sulph calc, Hypericum, lgnatia, Ruta, Staphysagria NDC 69685-0121 |
HYPERICUM PERFORATUM 10 [hp_X]/mL; STRYCHNOS IGNATII SEED 30 [hp_X]/mL; SILICON DIOXIDE 8 [hp_X]/mL; CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X]/mL; ECHINACEA ANGUSTIFOLIA 3 [hp_X]/mL; CALCIUM SULFIDE 8 [hp_X]/mL; RUTA GRAVEOLENS FLOWERING TOP 12 [hp_X]/mL; ARNICA MONTANA 3 [hp_X]/mL; MATRICARIA RECUTITA 5 [hp_X]/mL; ECHINACEA PURPUREA 3 [hp_X]/mL; LEDUM PALUSTRE TWIG 6 [hp_X]/mL; DELPHINIUM STAPHISAGRIA SEED 8 [hp_X]/mL | Spray Oral |
StellaLife, Inc. | OTC |
- Recalling firm
- Homeocare Laboratories, Inc.
- NDC code
- 69685-121-01
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Jun 5, 2024 · FDA notice with lot numbers
- FDA recall number
- D-0609-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Homeocare Laboratories, Inc.
All 2024 recalls
Class II · Moderate risk
StellaLife VEGA Oral Care Gel
cGMP deviations
Class II · Moderate risk
StellaLife VEGA Oral Care Gel
cGMP deviations
Class II · Moderate risk
StellaLife VEGA Oral Care Spray
cGMP deviations
Other microbial contamination recalls from 2024
All microbial contamination recalls
Class I · High risk
Atovaquone Oral Suspension
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Class II · Moderate risk
Vivier Sheer SPF 30 Mineral With Antioxidants
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
Barrier Therapy Skin Protectant Cream
Microbial contamination of non-sterile Products -
Class I · High risk
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection)
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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