Status
Ongoing
Drug Enforcement D-0158-2024
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.
Classification
Class I
Report Date
December 27, 2023
Termination Date
—
Product Information
- 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
- Product quantity
- 173 capsules
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Florida, Bahamas, Turks & Caicos Islands
Location & Firm
- Recalling firm
- Noah's Wholesale LLC
- Address
-
4720 Nw 165th St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0158-2024
- Event ID
- 93231
- Recall initiation date
- October 16, 2023
- Center classification date
- December 21, 2023
- Code info
- Lot# 03032021 Exp: 12/31/2027
- More code info
- —