FDA recall D-1084-2017

HARDCORE FORMULATIONS · Class I · drug

Product

ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0

Reason for recall

Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2017-07-05
Report date
2017-08-23
Termination date
2020-10-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Marcos, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1084-2017