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
ESTRASTAIN PRO-ANABOLIC MASS AND HARDENING COMPLEX (Estra-4,9,11-triene-3,17-dione 15mg, 2a-3a-epithio-17a-methyl-5a-androstan-17b-ol 10 mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, 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-0988-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 12, 2014
- FDA report date
- May 13, 2015
- Quantity
- 12,166 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Anabolic Science Labs, LLC
Original FDA data
Every field from FDA enforcement report D-0988-2015, 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-0988-2015
- Classification
- Class I
- Recalling firm
- Anabolic Science Labs, LLC
- Product quantity
- 12,166 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
- ESTRASTAIN PRO-ANABOLIC MASS AND HARDENING COMPLEX (Estra-4,9,11-triene-3,17-dione 15mg, 2a-3a-epithio-17a-methyl-5a-androstan-17b-ol 10 mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, 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