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

FDA recall notice · announced December 27, 2023 · Noah's Wholesale

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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

Reason for recall

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.

Notes

Distribution: Florida, Bahamas, Turks & Caicos Islands
Lot/code information: Lot# 03032021 Exp: 12/31/2027
Quantity: 173 capsules
Status: Ongoing
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.