Reported Jun 14, 2017 · Terminated

Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use…

Qualgen

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Qualgen · 14844 Bristol Park Blvd · Edmond, OK · 73013-1891

Is this the product you have?

  • Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond
  • OK 73013 NDC69761-020-01
Lot codes and dates
    • Lot# C022
    • Exp. 08/21/17 Lot# B143
    • Exp. 11/22/17 Lot# B104
    • Exp. 09/27/17 Lot# B073
    • Exp. 08/1/17 Lot# B052
    • Exp. 06/13/17
Amount recalled
4,468 pellets.

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

  • Nationwide

Why it was recalled

CGMP deviations- Lack of Quality Assurance

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 24, 2021 · Data as of Sep 19, 5:48 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.