FDA Recall D-1142-2017
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 STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-3-one azine 10 mg) capsule, packaged in 60-count bottle, Andropharm.com, UPC: 6 42125 50294 8
Reason for recall
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Recall record
- Recall number
D-1142-2017- 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