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Recall Observatory FDA recall evidence

Drug product

D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1

D-1085-2017

July 05, 2017

Class I

Product summary

Firm
HARDCORE FORMULATIONS
Event
Event 77660
Status
Terminated
Classification
Class I
Quantity
1440 bottles
Official record key
drug-enforcement:D-1085-2017

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.