Drug 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
D-1142-2017
Product summary
- Firm
- Andropharm, LLC
- Event
- Event 77664
- Status
- Terminated
- Classification
- Class I
- Quantity
- 150 bottles
- Official record key
drug-enforcement:D-1142-2017
Official wording
Reason: Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Code information: All lots remaining within expiry.
Distribution pattern: Florida
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.