July 2014 FDA Recall Drug by Physician Preferred Medical, Llc
D-0982-2015 - Non-Sterility

This Class I drug recall was voluntarily initiated by Physician Preferred Medical, Llc on July 24, 2014 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed in AZ and KS and the recall is currently terminated.

Recall Number: D-0982-2015

Reason for Recall
Non-Sterility: The recalled lot failed sterility testing.
Initiated
07-24-2014
Reported
05-13-2015
Quantity
122 Pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70703
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Physician Preferred Medical, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AZ and KS
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-17-2017
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 06241401-070714Q, Exp 12/14