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Recall Observatory FDA recall evidence

Drug product

StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01

D-0890-2023

June 05, 2023

Class II

Product summary

Firm
Homeocare Laboratories, Inc.
Event
Event 92453
Status
Terminated
Classification
Class II
Quantity
33,109/1 fl. oz. tubes
Official record key
drug-enforcement:D-0890-2023

Official wording

Reason: cGMP deviations

Code information: Lot #2407, exp. date Feb-24; 2409A, exp. date Apr-24; 2409B, exp. date May-24

Distribution pattern: Product was distributed USA nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations