PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: December 27, 2023 Initiated: October 16, 2023 #D-0158-2024

Product Description

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.

Details

Recalling Firm
Noah's Wholesale LLC
Units Affected
173 capsules
Distribution
Florida, Bahamas, Turks & Caicos Islands
Location
Miami Lakes, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by Noah's Wholesale LLC. Units affected: 173 capsules.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 27, 2023. Severity: Critical. Recall number: D-0158-2024.