D-1084-2017 Class I Terminated
FDA drug recall D-1084-2017 was initiated by HARDCORE FORMULATIONS on July 5, 2017 and is designated Class I. Reason for recall: Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine. The recall status is terminated (terminated October 5, 2020). Affected quantity: 1490 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 23, 2017
- Initiation Date
- July 5, 2017
- Termination Date
- October 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1490 bottles
Product Description
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 Pattern
Nationwide
Code Information
All lots remaining within expiry.