Reported Jun 14, 2017 · Terminated
Estradiol 22 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 22 mg pellet 99.5% Estradiol USP.5% Stearic Acid NFin 1 count12 countand 30 count bottlesSterile Office Use OnlyFor Subcutaneous Use Only Rx Only
- Manufactured by
Qualgen 14844 Bristol Park Blvd EdmondOK 73013 NDC 69761-022-01
- Lot codes and dates
Lot # B128Exp. 11/1/17 Lot # B075Exp. 08/3/17
- Amount recalled
- 1,666 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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