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Recall Observatory FDA recall evidence

Drug product

HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59

D-0561-2022

January 28, 2022

Class I

Product summary

Firm
Esupplementsales, LLC
Event
Event 89501
Status
Terminated
Classification
Class I
Quantity
500 cartons
Official record key
drug-enforcement:D-0561-2022

Official wording

Reason: Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.

Code information: Lot: 2107, Exp July 2024

Distribution pattern: Nationwide in the USA via Amazon at www.amazon.com

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.