Reported Dec 2, 2015 · Terminated

Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC…

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 USP 99.5%
    • .5% Stearic Acid NF Pellets
    • 3 mL
    • one-count vials
    • 6 mg (NDC 69761-006-01)
    • 10 mg (NDC 69761-010-01)
    • 12.5 mg (NDC 69761-012-01)
    • 15 mg (NDC 69761-015-01)
    • 18 mg (NDC 69761-018-01)
    • 20 mg (NDC 69761-020-01)
    • 22 mg (NDC 69761-022-01)
    • 25 mg (NDC 69761-025-01)
    • Rx only
    • Compounded by Qualgen
    • Edmond
    • Oklahoma 73013
Lot codes and dates

19 of 19 products

Products covered by this recall
#Product as published
1A002 Exp.: 10/23/2015
2A003 Exp.: 10/25/2015
3A009 Exp.: 11/01/2015
4A011 Exp.: 11/2/2015
5A014 Exp.: 11/8/2015
6A016 Exp.: 11/10/2015
7A027 Exp.: 11/20/2015
8A028 Exp.: 11/21/2015
9A030 Exp.: 11/22/2015
10A032 Exp.: 11/23/2015
11A037 Exp.: 11/24/2015
12A039 Exp.: 11/27/2015
13A042 Exp.: 11/28/2015
14A044 Exp.: 11/29/2015
15A050 Exp.: 12/06/2015
16A051 Exp.: 12/10/2015
17A053 Exp.: 12/12/2015
18A062 Exp.: 12/20/2015
19A065 Exp.: 12/28/2015
Amount recalled
4,221 vials

This recall covers 2 products

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

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility 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 Mar 30, 2017 · Data as of Sep 19, 6:24 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.