Hard Steel Capsules Recalled for Undeclared Acetaminophen and Sildenafil
Hard Steel Capsules contain undeclared acetaminophen and sildenafil and were marketed without FDA approval. All 729 units distributed nationwide and internationally are included in the recall.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. Although no illnesses or injuries have been reported, the undeclared presence of pharmaceutical ingredients in an unapproved product represents a serious health risk.
Plain-English summary
Supercore Products Group Inc. is recalling Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20, and 30 units. FDA analysis found these capsules contain undeclared acetaminophen and sildenafil, pharmaceutical ingredients not listed on the product packaging.
The products were marketed without FDA approval. Hard Steel Capsules are not authorized to contain acetaminophen and sildenafil without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
A total of 729 units have been distributed, including nationwide distribution in the United States and distribution to Canada, Israel, Australia, United Kingdom, Pakistan, Morocco, and the Republic of Kosovo. All lots are included in this recall.
Consumers who have purchased these products should discontinue use immediately. Anyone who has consumed these capsules and has health concerns should contact their healthcare provider.
The recalled product
- Product
- Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
- Manufacturer
- Supercore Products Group Inc.
- Category
- Drug
- Hazard
- undeclared-acetaminophen
- undeclared-sildenafil
- unapproved-product
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
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