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Recall Observatory FDA recall evidence

Drug product

STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01

D-0609-2024

June 05, 2024

Class I

Product summary

Firm
Homeocare Laboratories, Inc.
Event
Event 94782
Status
Terminated
Classification
Class I
Quantity
31,811 x 1 fl. oz. spray bottle
Official record key
drug-enforcement:D-0609-2024

Official wording

Reason: Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms

Code information: Lot # 2552, exp. date 02-28-2026

Distribution pattern: Nationwide to 60 Physician offices

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination