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Recall Observatory FDA recall evidence

Drug product

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

D-0887-2023

June 05, 2023

Class II

Product summary

Firm
Homeocare Laboratories, Inc.
Event
Event 92453
Status
Terminated
Classification
Class II
Quantity
16,587 bottles
Official record key
drug-enforcement:D-0887-2023

Official wording

Reason: cGMP deviations

Code information: Lot # 2396, exp. date Apr-24

Distribution pattern: Product was distributed USA nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations