Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Reported: October 9, 2024 Initiated: July 12, 2024 #D-0003-2025
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.
Details
- Recalling Firm
- Supercore Products Group Inc.
- Units Affected
- 729
- Distribution
- Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.. Recalled by Supercore Products Group Inc.. Units affected: 729.
Why was this product recalled? ▼
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 9, 2024. Severity: Critical. Recall number: D-0003-2025.
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