Reported Jun 14, 2017 · Terminated

Estradiol 6 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 6 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 NDC69761-006-01
Lot codes and dates

10 of 10 products

Products covered by this recall
#Product as published
1Lot# C046
2Exp. 03/15/18 Lot# C025
3Exp. 08/23/17 Lot# B159
4Exp. 12/28/17 Lot# B121
5Exp. 10/10/17 Lot# B118
6Exp. 10/17/17 Lot# B086
7Exp. 08/29/17 Lot# B068
8Exp. 07/11/17 Lot# B053
9Exp. 06/14/17 Lot# B034
10Exp. 04/26/17
Amount recalled
4,815 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.

Want the full recall guide?

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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, 6:30 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.