Why it was 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.
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
Lot numbers, UPCs & expiration codes
Lot# 03032021 Exp: 12/31/2027
Where it was sold
Florida, Bahamas, Turks & Caicos Islands
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0158-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Oct 16, 2023
- FDA report date
- Dec 27, 2023
- Quantity
- 173 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noah's Wholesale LLC
Original FDA data
Every field from FDA enforcement report D-0158-2024, exactly as published.
Show all FDA fields
- City
- Miami Lakes
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 93231
- Address
- 4720 Nw 165th St
- Code information
- Lot# 03032021 Exp: 12/31/2027
- Postal code
- 33014-6423
- Report date
- Dec 27, 2023
- Product type
- Drugs
- Recall number
- D-0158-2024
- Classification
- Class I
- Recalling firm
- Noah's Wholesale LLC
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Florida, Bahamas, Turks & Caicos Islands
- Recall initiation date
- Oct 16, 2023
- Initial firm notification
- Telephone
- Center classification date
- Dec 21, 2023