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Class I: serious health riskTerminated

Homeocare Laboratories STELLALIFE VEGA Oral Care Recall

STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by:…

Homeocare Laboratories, Inc. · Yonkers, NY

Risk level
Class I
Reported by FDA
Jul 24, 2024
Recall ID
D-0609-2024
Check your lot numberHow we source this data

Summary

Homeocare Laboratories recalled STELLALIFE VEGA Oral Care starting Jun 5, 2024. The FDA classified it as Class I (serious health risk) and published enforcement report D-0609-2024 on Jul 24, 2024. Reason: Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms. Status: Terminated.

Why it was recalled

Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms

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 numbers, UPCs & expiration codes

Lot # 2552, exp. date 02-28-2026

Where it was sold

Nationwide to 60 Physician offices

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0609-2024
Classification
Class I
Status
Terminated
Recall initiated
Jun 5, 2024
FDA report date
Jul 24, 2024
Quantity
31,811 x 1 fl. oz. spray bottle
Recall type
Voluntary: Firm initiated
Recalling firm
Homeocare Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0609-2024, exactly as published.

Show all FDA fields
City
Yonkers
State
NY
Status
Terminated
Country
United States
Event ID
94782
Address
7 Odell Plz Ste 142-146
Code information
Lot # 2552, exp. date 02-28-2026
Postal code
10701-1407
Report date
Jul 24, 2024
Product type
Drugs
Recall number
D-0609-2024
Classification
Class I
Recalling firm
Homeocare Laboratories, Inc.
Product quantity
31,811 x 1 fl. oz. spray bottle
Termination date
Nov 13, 2024
Reason for recall
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide to 60 Physician offices
Recall initiation date
Jun 5, 2024
Initial firm notification
Press Release
Center classification date
Jul 17, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0609-2024, published Jul 24, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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