Why it was recalled
Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
Product description
Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA
Lot numbers, UPCs & expiration codes
All lots within expiry.
Where it was sold
Product was distributed in the United States.
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-0470-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 19, 2017
- FDA report date
- Jan 31, 2018
- Quantity
- 10 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- www.blankterrmall.com
Original FDA data
Every field from FDA enforcement report D-0470-2018, exactly as published.
Show all FDA fields
- City
- Olean
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 78643
- Address
- 2251 Constitution Ave
- Code information
- All lots within expiry.
- Postal code
- 14760-1840
- Report date
- Jan 31, 2018
- Product type
- Drugs
- Recall number
- D-0470-2018
- Classification
- Class I
- Recalling firm
- www.blankterrmall.com
- Product quantity
- 10 boxes
- Termination date
- Dec 11, 2018
- Reason for recall
- Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA
- Distribution pattern
- Product was distributed in the United States.
- Recall initiation date
- Nov 19, 2017
- Initial firm notification
- Press Release
- Center classification date
- Feb 20, 2018