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Class II: temporary or reversible health riskTerminated

Homeocare Laboratories StellaLife VEGA Oral Care Gel Recall

StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc

Homeocare Laboratories, Inc. · Yonkers, NY

Risk level
Class II
Reported by FDA
Jul 5, 2023
Recall ID
D-0889-2023
Check your lot numberHow we source this data

Summary

Homeocare Laboratories recalled StellaLife VEGA Oral Care Gel starting Jun 5, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0889-2023 on Jul 5, 2023. Reason: cGMP deviations. Status: Terminated.

Why it was recalled

cGMP deviations

Product description

StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02

Lot numbers, UPCs & expiration codes

Lot #2334, exp. date Sep-23; 2363, exp. date Nov-23; 2365, exp. date Jan-24

Where it was sold

Product was distributed USA nationwide.

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-0889-2023
Classification
Class II
Status
Terminated
Recall initiated
Jun 5, 2023
FDA report date
Jul 5, 2023
Quantity
38,105/1 fl. oz. tubes
Recall type
Voluntary: Firm initiated
Recalling firm
Homeocare Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0889-2023, exactly as published.

Show all FDA fields
City
Yonkers
State
NY
Status
Terminated
Country
United States
Event ID
92453
Address
7 Odell Plz Ste 142-146
Code information
Lot #2334, exp. date Sep-23; 2363, exp. date Nov-23; 2365, exp. date Jan-24
Postal code
10701-1407
Report date
Jul 5, 2023
Product type
Drugs
Recall number
D-0889-2023
Classification
Class II
Recalling firm
Homeocare Laboratories, Inc.
Product quantity
38,105/1 fl. oz. tubes
Termination date
Sep 16, 2024
Reason for recall
cGMP deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02
Distribution pattern
Product was distributed USA nationwide.
Recall initiation date
Jun 5, 2023
Initial firm notification
Letter
Center classification date
Jun 26, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0889-2023, published Jul 5, 2023. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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