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Recall Observatory FDA recall evidence

Drug product

RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.

D-0645-2022

February 10, 2022

Class I

Product summary

Firm
Positive Health
Event
Event 89606
Status
Terminated
Classification
Class I
Quantity
5,500 cartons
Official record key
drug-enforcement:D-0645-2022

Official wording

Reason: Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Code information: Lot # 48658908, Exp. date 09/09/2023

Distribution pattern: Product was distributed nationwide via the internet through Amazon Marketplace.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.