Home / Recalls / Andropharm, LLC / D-1142-2017

D-1142-2017 Class I Terminated

Recalled by Andropharm, LLC — Boca Raton, FL

Recall Details

Product Type: Drugs
Report Date: September 20, 2017
Initiation Date: June 6, 2017
Termination Date: June 2, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 150 bottles

Product Description

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 Pattern

Florida

Code Information

All lots remaining within expiry.