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Recall Observatory FDA recall evidence

Drug product

Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.

D-0003-2025

July 12, 2024

Class I

Product summary

Firm
Supercore Products Group Inc.
Event
Event 94949
Status
Ongoing
Classification
Class I
Quantity
729
Official record key
drug-enforcement:D-0003-2025

Official wording

Reason: Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.

Code information: All lots

Distribution pattern: Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.