Recalls / Class I
Class ID-0986-2015
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
HALO-70 MEGA MASS BUILDER (4-chloro-17a-methyl-androst-1,4-diene-3b,17b-diol 35mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
- Affected lot / code info
- All lots
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.
Recalling firm
- Firm
- Anabolic Science Labs, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 900 S Kentucky Ave, N/A, Winter Park, Florida 32789-4751
Distribution
- Quantity
- 515 bottles
- Distribution pattern
- US Nationwide and Singapore
Timeline
- Recall initiated
- 2014-12-12
- FDA classified
- 2015-05-05
- Posted by FDA
- 2015-05-13
- Terminated
- 2017-02-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0986-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.