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Recall Observatory FDA recall evidence

Drug product

STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-143-16

D-0610-2024

June 05, 2024

Class II

Product summary

Firm
Homeocare Laboratories, Inc.
Event
Event 94782
Status
Terminated
Classification
Class II
Quantity
31,110 x 16 fl. oz. bottle
Official record key
drug-enforcement:D-0610-2024

Official wording

Reason: Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism

Code information: Lot # 2550, 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