FDA recall D-1142-2017

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.

Distribution

Florida

Key facts

Status

Terminated

Initiation date

2017-06-06

Report date

2017-09-20

Termination date

2020-06-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boca Raton, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1142-2017