FDA Recall D-1084-2017
HARDCORE FORMULATIONS · San Marcos, TX
Class I — life-threatening Terminated 1188 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-1084-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2017-07-05
- Classified by FDA Center
- 2017-08-14
- FDA published
- 2017-08-23
- Terminated
- 2020-10-05
- Recalling firm
- HARDCORE FORMULATIONS
- Firm location
- San Marcos, TX