STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street,
Summary
The FDA issued a Class I for STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distribut by Homeocare Laboratories, Inc.. Reason: Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms.
Details
Source
Drug Recall
External ID
D-0609-2024
Action Date
2024-07-24
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot # 2552, exp. date 02-28-2026
Quantity Affected: 31,811 x 1 fl. oz. spray bottle
Reason for Recall
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Distribution
Nationwide to 60 Physician offices
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-05
Company
Yonkers, NY
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 41 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Homeocare Laboratories, Inc. has 13 FDA actions in our database, including 13 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Homeocare Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Homeocare Laboratories, Inc. have FDA actions?
Homeocare Laboratories, Inc. has 13 FDA actions in our database, including 13 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0609-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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