FDA Recall D-1143-2017
Andropharm, LLC · Boca Raton, FL
Class I — life-threatening Terminated 1092 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6 42125 50292 4
Reason for recall
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Recall record
- Recall number
D-1143-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Florida
- Recall initiated
- 2017-06-06
- Classified by FDA Center
- 2017-09-12
- FDA published
- 2017-09-20
- Terminated
- 2020-06-02
- Recalling firm
- Andropharm, LLC
- Firm location
- Boca Raton, FL