Drug product
THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7
D-0158-2024
Product summary
- Event
- Event 93231
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 173 capsules
- Official record key
drug-enforcement:D-0158-2024
Official wording
Reason: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Code information: Lot# 03032021 Exp: 12/31/2027
Distribution pattern: Florida, Bahamas, Turks & Caicos Islands
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.