Epel 18 mg Estradiol Pellet recalled over sterility concerns

Recall date

July 24, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Physician Preferred Medical, LLC recalls Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administration Only, Not for Resale or Dispensing to…

Recall number

D-0982-2015

FDA classification

Class I

Brand / firm

Physician Preferred Medical, LLC

Sold / distributed

AZ and KS

Why it was recalled

Non-Sterility: The recalled lot failed sterility testing.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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