PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: September 20, 2017 Initiated: June 6, 2017 #D-1142-2017

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.

Details

Recalling Firm
Andropharm, LLC
Units Affected
150 bottles
Distribution
Florida
Location
Boca Raton, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by Andropharm, LLC. Units affected: 150 bottles.
Why was this product recalled?
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 20, 2017. Severity: Critical. Recall number: D-1142-2017.