FDA Recall D-0158-2024
Noah's Wholesale LLC · Miami Lakes, FL
Class I — life-threatening Ongoing 941 days on record
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.
Recall record
- Recall number
D-0158-2024- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Florida, Bahamas, Turks & Caicos Islands
- Recall initiated
- 2023-10-16
- Classified by FDA Center
- 2023-12-21
- FDA published
- 2023-12-27
- Recalling firm
- Noah's Wholesale LLC
- Firm location
- Miami Lakes, FL
Operational response
A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.
For the official FDA enforcement record, see FDA's Recall Search.