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Recall Observatory FDA recall evidence

Drug product

SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, Net Wt. 2.6 oz (73g) NDC# 41595-5509-2 UPC 8 83484 71717 2 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912

D-0783-2020

November 20, 2019

Class III

Product summary

Firm
Idelle Labs
Event
Event 84620
Status
Terminated
Classification
Class III
Quantity
Unknown
Official record key
drug-enforcement:D-0783-2020

Official wording

Reason: Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.

Code information: Lots: 19273K1, 19274K1, 19274K2, 19725K1, 19725K2, 19726K1

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.