Reported Nov 14, 2018 · Terminated
Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30…
Qualgen, LLC
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, LLC · 14844 Bristol Park Blvd · Edmond, OK · 73013-1891
Is this the product you have?
Estradiol 10mg pellet1 count (NDC 69761-010-01)6 count (NDC 69761-010-06)12 count (NDC 69761-010-12)and 30 count (NDC 69761-010-30) vialsRx OnlyQualgenLLCEdmondOK 73013
- Lot codes and dates
- Lots
- C262 BUD12/20/2018
- D067 BUD03/21/2019
- D072 BUD03/28/2019
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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