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Recall Observatory FDA recall evidence

Drug product

StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16

D-0886-2023

June 05, 2023

Class II

Product summary

Firm
Homeocare Laboratories, Inc.
Event
Event 92453
Status
Terminated
Classification
Class II
Quantity
130,762/16 oz. tottles
Official record key
drug-enforcement:D-0886-2023

Official wording

Reason: cGMP deviations

Code information: Lot # 2357B,2333, exp. date Sep-2; 2367C, 2367D, exp. date Nov-23; 2367E, 2367F, exp. date Jan-24; 2395A, 2406, exp. date Feb-2; 2395B, exp. date Mar-24; 2395C, 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