D-0571-2023 Class I Ongoing
FDA drug recall D-0571-2023 was initiated by Gadget Island, Inc on April 26, 2023 and is designated Class I. Reason for recall: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual en… The recall status is ongoing. Affected quantity: 628 blister cards.
Recall Details
- Product Type
- Drugs
- Report Date
- May 10, 2023
- Initiation Date
- April 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 628 blister cards
Product Description
Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0.
Reason for Recall
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Distribution Pattern
Nationwide in the USA.
Code Information
No lot number, Exp: 06/2026