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