FDA recall D-1143-2017

Andropharm, LLC · Class I · drug

Product

ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6 42125 50292 4

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-1143-2017