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Recall Observatory FDA recall evidence

Drug product

BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5

D-0247-2018

November 29, 2017

Class I

Product summary

Firm
Blue Fusion Natural
Event
Event 78634
Status
Terminated
Classification
Class I
Quantity
300 pill cards
Official record key
drug-enforcement:D-0247-2018

Official wording

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.

Code information: All lots

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.