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Recall Observatory FDA recall evidence

Drug product

Burro en Primavera, 2 capsules, UPC 638632431055

D-0370-2021

March 31, 2021

Class II

Product summary

Firm
QMart
Event
Event 87751
Status
Ongoing
Classification
Class II
Quantity
500 boxes
Official record key
drug-enforcement:D-0370-2021

Official wording

Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Code information: All

Distribution pattern: USA Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.