Drug Enforcement D-0003-2025

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

Status

Ongoing

Classification

Class I

Report Date

October 9, 2024

Termination Date

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Product Information

Product description
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Product quantity
729
Reason for recall
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Recall initiation reason
—
Initial firm notification
Press Release
Distribution pattern
Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)

Location & Firm

Recalling firm
Supercore Products Group Inc.
Address
230 Peachtree St Nw, Ste 2200

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0003-2025
Event ID
94949
Recall initiation date
July 12, 2024
Center classification date
October 2, 2024
Code info
All lots
More code info
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