FDA Recall D-0982-2015
Physician Preferred Medical, LLC · Oklahoma City, OK
Class I — life-threatening Terminated 908 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Non-Sterility: The recalled lot failed sterility testing.
Recall record
- Recall number
D-0982-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- AZ and KS
- Recall initiated
- 2014-07-24
- Classified by FDA Center
- 2015-05-04
- FDA published
- 2015-05-13
- Terminated
- 2017-01-17
- Recalling firm
- Physician Preferred Medical, LLC
- Firm location
- Oklahoma City, OK