FDA Recall D-1151-2014
Mira Health Products Ltd. · Farmingdale, NY
Class I — life-threatening Terminated 420 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone Labs, Boca Raton, FL
Reason for recall
Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug
Recall record
- Recall number
D-1151-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide
- Recall initiated
- 2013-07-22
- Classified by FDA Center
- 2014-03-05
- FDA published
- 2014-03-12
- Terminated
- 2014-09-15
- Recalling firm
- Mira Health Products Ltd.
- Firm location
- Farmingdale, NY