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Recall Observatory FDA recall evidence

Drug product

Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottles, Distributed by: The Larkspur Group Inc. South Norwalk, CT 06854

D-0446-2023

February 24, 2023

Class II

Product summary

Firm
Ecometics, Inc.
Event
Event 91719
Status
Terminated
Classification
Class II
Quantity
18,000 bottles
Official record key
drug-enforcement:D-0446-2023

Official wording

Reason: CGMP DEVIATIONS

Code information: Lot #: a) and b) 2E018A, 2E021A, 2E286A, 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