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Recall Observatory FDA recall evidence

Drug product

Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administration Only, Not for Resale or Dispensing to an Individual Patient, Rx Only, Preferred Physician Medical LLC, 405-551-8216

D-0982-2015

July 24, 2014

Class I

Product summary

Firm
Physician Preferred Medical, LLC
Event
Event 70703
Status
Terminated
Classification
Class I
Quantity
122 Pellets
Official record key
drug-enforcement:D-0982-2015

Official wording

Reason: Non-Sterility: The recalled lot failed sterility testing.

Code information: Lot # 06241401-070714Q, Exp 12/14

Distribution pattern: AZ and KS

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility: The recalled lot failed sterility testing.