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Class III: unlikely to cause harmTerminated

Qualgen ESTRADIOL 20mg PELLET Recall

ESTRADIOL 20mg PELLET, 1-count 3ml amber vial

Qualgen, LLC · Edmond, OK

Risk level
Class III
Reported by FDA
Jul 11, 2018
Recall ID
D-0892-2018
Check your lot numberHow we source this data

Summary

Qualgen recalled ESTRADIOL 20mg PELLET starting Jun 8, 2018. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0892-2018 on Jul 11, 2018. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. Status: Terminated.

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Exp Date.

Product description

ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01

Lot numbers, UPCs & expiration codes

lot# C211 Exp. date 10/03/2018; C257 Exp. date 12/14/2018 and lot # D001 exp. date 01/02/19

Where it was sold

Nationwide in the USA

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-0892-2018
Classification
Class III
Status
Terminated
Recall initiated
Jun 8, 2018
FDA report date
Jul 11, 2018
Quantity
2,940 pellets
Recall type
Voluntary: Firm initiated
Recalling firm
Qualgen, LLC

Original FDA data

Every field from FDA enforcement report D-0892-2018, exactly as published.

Show all FDA fields
City
Edmond
State
OK
Status
Terminated
Country
United States
Event ID
80203
Address
14844 Bristol Park Blvd
Code information
lot# C211 Exp. date 10/03/2018; C257 Exp. date 12/14/2018 and lot # D001 exp. date 01/02/19
Postal code
73013-1891
Report date
Jul 11, 2018
Product type
Drugs
Recall number
D-0892-2018
Classification
Class III
Recalling firm
Qualgen, LLC
Product quantity
2,940 pellets
Termination date
Nov 25, 2020
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date.
Voluntary / mandated
Voluntary: Firm initiated
Product description
ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01
Distribution pattern
Nationwide in the USA
Recall initiation date
Jun 8, 2018
Initial firm notification
Letter
Center classification date
Jun 29, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0892-2018, published Jul 11, 2018. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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