Reported Jun 14, 2017 · Terminated

Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile…

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 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only
  • Manufactured by
    • Qualgen 14844 Bristol Park Blvd Edmond
    • OK 73013
  • NDC69761-012-01
Lot codes and dates
    • Lot# C044
    • Exp. 03/14/18 Lot# C013
    • Exp. 07/23/17 Lot# B150
    • Exp. 12/6/17 Lot# B119
    • Exp. 10/18/17 Lot# B097
    • Exp. 09/14/17 Lot# B061
    • Exp. 07/5/17
Amount recalled
4,883 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, 5:52 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.