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Supercore Products Group Inc.

HIGH RISKHQ: — · Private · Founded —
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INTELLIGENCE

Showing 2 of 2 briefs on Supercore Products Group Inc.
REGULATORY INTELLIGENCE·Recall

FDA Class I Recall: Supercore Products Group's Gold Hard Steel Plus Liquid Tainted with Undeclared APIs, Unapproved Marketing

Supercore Products Group Inc. faces a Class I FDA recall for Gold Hard Steel Plus Liquid, distributed nationwide and internationally. The product contains undeclared acetaminophen and sildenafil, marketed without an approved NDA/ANDA. This poses significant health risks and demands immediate action from global procurement and regulatory teams to reassess supplier vetting processes.

90-Day Activity
Supercore Products GroupNail Repair Pen Liquid
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2024-10-09 Recall
REGULATORY INTELLIGENCE·Recall

FDA Class I Recall: Par Sterile Products' Treprostinil Injection Impacted by Particulate Matter

Par Sterile Products LLC has initiated a Class I recall for 466 vials of Treprostinil Injection (Lot#: 57014) due to particulate matter, impacting nationwide U.S. distribution. This high-severity event demands immediate attention from procurement and regulatory teams to assess supply chain integrity and patient safety risks associated with this critical cardiovascular drug. Decision-makers must evaluate current inventory and potential sourcing disruptions.

90-Day Activity
Supercore Products GroupTreprostinil DiolamineHSN 3004.90
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2024-04-03 Recall