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Recall Observatory FDA recall evidence

Drug product

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

D-1084-2017

July 05, 2017

Class I

Product summary

Firm
HARDCORE FORMULATIONS
Event
Event 77660
Status
Terminated
Classification
Class I
Quantity
1490 bottles
Official record key
drug-enforcement:D-1084-2017

Official wording

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

Code information: All lots remaining within expiry.

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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