D-0004-2025 Class I Ongoing
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
- 615
Product Description
Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
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