Why it was recalled
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Product description
ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
Nationwide
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-1084-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 5, 2017
- FDA report date
- Aug 23, 2017
- Quantity
- 1490 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- HARDCORE FORMULATIONS
Original FDA data
Every field from FDA enforcement report D-1084-2017, exactly as published.
Show all FDA fields
- City
- San Marcos
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 77660
- Address
- 3012 Fm 621 Ste B
- Code information
- All lots remaining within expiry.
- Postal code
- 78666-1668
- Report date
- Aug 23, 2017
- Product type
- Drugs
- Recall number
- D-1084-2017
- Classification
- Class I
- Recalling firm
- HARDCORE FORMULATIONS
- Product quantity
- 1490 bottles
- Termination date
- Oct 5, 2020
- Reason for recall
- Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 5, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 14, 2017