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Class I: serious health riskTerminated

Physician Preferred Medical Epel 18 mg Estradiol Pellet Recall

Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administration Only,…

Physician Preferred Medical, LLC · Oklahoma City, OK

Risk level
Class I
Reported by FDA
May 13, 2015
Recall ID
D-0982-2015
Check your lot numberHow we source this data

Summary

Physician Preferred Medical recalled Epel 18 mg Estradiol Pellet starting Jul 24, 2014. The FDA classified it as Class I (serious health risk) and published enforcement report D-0982-2015 on May 13, 2015. Reason: Non-Sterility: The recalled lot failed sterility testing. Status: Terminated.

Why it was recalled

Non-Sterility: The recalled lot failed sterility testing.

Product description

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

Lot numbers, UPCs & expiration codes

Lot # 06241401-070714Q, Exp 12/14

Where it was sold

AZ and KS

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0982-2015
Classification
Class I
Status
Terminated
Recall initiated
Jul 24, 2014
FDA report date
May 13, 2015
Quantity
122 Pellets
Recall type
Voluntary: Firm initiated
Recalling firm
Physician Preferred Medical, LLC

Original FDA data

Every field from FDA enforcement report D-0982-2015, exactly as published.

Show all FDA fields
City
Oklahoma City
State
OK
Status
Terminated
Country
United States
Event ID
70703
Address
3300 NW 56th Street
Address (line 2)
Suite 101
Code information
Lot # 06241401-070714Q, Exp 12/14
Postal code
73112
Report date
May 13, 2015
Product type
Drugs
Recall number
D-0982-2015
Classification
Class I
Recalling firm
Physician Preferred Medical, LLC
Product quantity
122 Pellets
Termination date
Jan 17, 2017
Reason for recall
Non-Sterility: The recalled lot failed sterility testing.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
AZ and KS
Recall initiation date
Jul 24, 2014
Initial firm notification
Letter
Center classification date
May 4, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0982-2015, published May 13, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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