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StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16

Drug Recall

Official source record

Recall number
D-0887-2023
Event ID
92453
Classification
Class II
Status
Terminated
Recalling company
Homeocare Laboratories, Inc.
Reason for recall
cGMP deviations
Report date
July 5, 2023
Recall initiation date
June 5, 2023
Termination date
September 16, 2024
Distribution pattern
Product was distributed USA nationwide.

Drug product identifiers

Manufacturer
StellaLife, Inc.
Brand name
STELLALIFE VEGA ORAL CARE COCONUT
Generic name
RISNE
Substance names
APIS MELLIFERA; AZADIRACHTA INDICA BARK; CALENDULA OFFICINALIS FLOWER; ECHINACEA PURPUREA; OKOUBAKA AUBREVILLEI BARK; PHOSPHORUS; PLANTAGO MAJOR; STRONTIUM; THUJA OCCIDENTALIS LEAFY TWIG
Product NDC
69685-113
Package NDC
69685-113-16
Route
DENTAL

Where this information comes from

View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

Is this recall still active?

According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this medication?

Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.

Where can I find more official information?

The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.