FDA Recall D-0989-2015
Anabolic Science Labs, LLC · Winter Park, FL
Class I — life-threatening Terminated 789 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
SWOLL-250 SUPER MASS BUILDER QUAD STACK (18-Methylestr-4-en-3-one-17b-ol 15mg, 6-a-Chloro-androst-4-en-17b-ol-3-one 15mg, 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one 15mg, 2,17a-dimethyl-5a-androsta-1-en-17b-ol-3-one 3 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
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.
Recall record
- Recall number
D-0989-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- US Nationwide and Singapore
- Recall initiated
- 2014-12-12
- Classified by FDA Center
- 2015-05-05
- FDA published
- 2015-05-13
- Terminated
- 2017-02-08
- Recalling firm
- Anabolic Science Labs, LLC
- Firm location
- Winter Park, FL