D-0003-2025 Class I Ongoing
FDA drug recall D-0003-2025 was initiated by Supercore Products Group Inc. on July 12, 2024 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil. The recall status is ongoing. Affected quantity: 729.
Recall Details
- Product Type
- Drugs
- Report Date
- October 9, 2024
- Initiation Date
- July 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 729
Product Description
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Reason for Recall
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Distribution Pattern
Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)
Code Information
All lots