Class II · Moderate risk
STELLALIFE ADVANCED FORMULA Peppermint
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
StellaLife VEGA Oral Care Gel (Spray)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01
Affected NDC
69685-0112-01
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 Gel Gel NDC 69685-0112 |
LEDUM PALUSTRE TWIG 6 [hp_X]/mL; CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X]/mL; ECHINACEA ANGUSTIFOLIA 3 [hp_X]/mL; HYPERICUM PERFORATUM 10 [hp_X]/mL; STRYCHNOS IGNATII SEED 30 [hp_X]/mL; SILICON DIOXIDE 8 [hp_X]/mL; RUTA GRAVEOLENS FLOWERING TOP 12 [hp_X]/mL; ARNICA MONTANA 18 [hp_X]/mL; MATRICARIA RECUTITA 5 [hp_X]/mL; ECHINACEA PURPUREA 3 [hp_X]/mL; DELPHINIUM STAPHISAGRIA SEED 8 [hp_X]/mL; CALCIUM SULFIDE 8 [hp_X]/mL | Gel Dental|topical |
StellaLife, Inc. | OTC |
- Recalling firm
- Homeocare Laboratories, Inc.
- NDC code
- 69685-112-01
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0890-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 2023 recalls
Class I · High risk
STELLALIFE VEGA Oral Care
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Class II · Moderate risk
StellaLife VEGA Oral Care Gel
cGMP deviations
Class II · Moderate risk
StellaLife VEGA Oral Care Spray
cGMP deviations
Other cgmp deviation recalls from 2023
All cgmp deviation recalls
Class II · Moderate risk
Sertraline Tablets
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Class II · Moderate risk
Oxygen
cGMP Deviations
Class III · Low risk
V-FORCE Homeopathic
Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
Class II · Moderate risk
Strong Iodine Solution U.S.P.
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
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