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Recall Observatory FDA recall evidence

Drug product

Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 06854

D-0447-2023

February 24, 2023

Class II

Product summary

Firm
Ecometics, Inc.
Event
Event 91719
Status
Terminated
Classification
Class II
Quantity
4,210 metal tubes/folding carton
Official record key
drug-enforcement:D-0447-2023

Official wording

Reason: CGMP DEVIATIONS

Code information: Lot #: 2E021A, Exp. Date Jan-25

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP DEVIATIONS