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Recall Observatory FDA recall evidence

Drug product

SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA 19053-8433

D-1113-2015

May 21, 2015

Class II

Product summary

Firm
Medtech Products, Inc.
Event
Event 71319
Status
Terminated
Classification
Class II
Quantity
107,832 tins
Official record key
drug-enforcement:D-1113-2015

Official wording

Reason: Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin.

Code information: Lot #: 42451, Exp 09/17

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up: An incorrect