Class II · Moderate risk
STELLALIFE ADVANCED FORMULA Peppermint
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
StellaLife VEGA Oral Care Rinse (Risne)
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 Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16
Affected NDC
69685-0113-16
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 Coconut Risne NDC 69685-0113 |
CALENDULA OFFICINALIS FLOWER 1 [hp_X]/mL; APIS MELLIFERA 12 [hp_X]/mL; AZADIRACHTA INDICA BARK 1 [hp_X]/mL; THUJA OCCIDENTALIS LEAFY TWIG 3 [hp_X]/mL; ECHINACEA PURPUREA 1 [hp_X]/mL; PHOSPHORUS 12 [hp_X]/mL; PLANTAGO MAJOR 1 [hp_X]/mL; STRONTIUM 30 [hp_X]/mL; OKOUBAKA AUBREVILLEI BARK 6 [hp_X]/mL | Rinse Dental |
StellaLife, Inc. | OTC |
- Recalling firm
- Homeocare Laboratories, Inc.
- NDC code
- 69685-113-16
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0887-2023 · 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 Gel
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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