Why it was recalled
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Product description
PROFESSIONAL FORMEXX BLACK (AromaMaXX 250mg: 13-dimethyl-1,2,7,8,9,11,12,14,15,16-decahydro-cyclopenta[a]phenanthrene-3,6,17-trione,4-Androsten 4,17-beta-diol-3one), Capsules, 60 count bottle, Manufactured for: ANABOLIC SCIENCE LABS WINTER PARK, FL 32789
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
US Nationwide and Singapore
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-0990-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 12, 2014
- FDA report date
- May 13, 2015
- Quantity
- 22,353 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Anabolic Science Labs, LLC
Original FDA data
Every field from FDA enforcement report D-0990-2015, exactly as published.
Show all FDA fields
- City
- Winter Park
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 70317
- Address
- 900 S Kentucky Ave
- Code information
- All lots
- Postal code
- 32789-4751
- Report date
- May 13, 2015
- Product type
- Drugs
- Recall number
- D-0990-2015
- Classification
- Class I
- Recalling firm
- Anabolic Science Labs, LLC
- Product quantity
- 22,353 bottles
- Termination date
- Feb 8, 2017
- Reason for recall
- Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PROFESSIONAL FORMEXX BLACK (AromaMaXX 250mg: 13-dimethyl-1,2,7,8,9,11,12,14,15,16-decahydro-cyclopenta[a]phenanthrene-3,6,17-trione,4-Androsten 4,17-beta-diol-3one), Capsules, 60 count bottle, Manufactured for: ANABOLIC SCIENCE LABS WINTER PARK, FL 32789
- Distribution pattern
- US Nationwide and Singapore
- Recall initiation date
- Dec 12, 2014
- Initial firm notification
- Press Release
- Center classification date
- May 5, 2015