Class II · Moderate risk Ongoing
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
Reason Lack of Assurance of Sterility
Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
What was recalled
Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
- Recalling firm
- Supercore Products Group Inc.
- Origin
- GA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0004-2025
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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Class II · Moderate risk Ongoing
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