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 Pellets3 mLone-count vials6 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 onlyCompounded by QualgenEdmondOklahoma 73013
- Lot codes and dates
19 of 19 products
Products covered by this recall # Product as published 1 A002 Exp.: 10/23/2015 2 A003 Exp.: 10/25/2015 3 A009 Exp.: 11/01/2015 4 A011 Exp.: 11/2/2015 5 A014 Exp.: 11/8/2015 6 A016 Exp.: 11/10/2015 7 A027 Exp.: 11/20/2015 8 A028 Exp.: 11/21/2015 9 A030 Exp.: 11/22/2015 10 A032 Exp.: 11/23/2015 11 A037 Exp.: 11/24/2015 12 A039 Exp.: 11/27/2015 13 A042 Exp.: 11/28/2015 14 A044 Exp.: 11/29/2015 15 A050 Exp.: 12/06/2015 16 A051 Exp.: 12/10/2015 17 A053 Exp.: 12/12/2015 18 A062 Exp.: 12/20/2015 19 A065 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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