Stellalife Vega Oral Care Coconut Rinse
FDA Recall NDC 69685-113
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Stellalife Vega Oral Care Coconut (NDC 69685-113). A significant event, classified as Class II, was initiated on Jun 05, 2023 by Stellalife, Inc.. The reported reason for this action was: "cGMP deviations"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP deviations
Jun 05, 2023
Jul 05, 2023
16,587 bottles
Recall Profile & Regulatory Data
Event ID
92453
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Homeocare Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed USA nationwide.
Termination Date
Sep 16, 2024
Product Description
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16
Batch or Lot Expiration Information
Lot# 2396, exp. date Apr-24
Affected Packages Involved in this Recall
69685-113-16Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
