Reported Jun 14, 2017 · Terminated
Estradiol 10 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 10 mg pellet 99.5% Estradiol USP.5% Stearic Acid NF in 1 count12 countand 30 count bottlesSterile Office Use OnlyFor Subcutaneous
- Use Only Rx Only Manufactured byQualgen 14844 Bristol Park Blvd Edmond
- OK 73013 NDC69761-010-01
- Lot codes and dates
Lot# C021Exp. 08/20/17 Lot# B160Exp. 12/29/17 Lot# B140Exp. 11/15/17 Lot# B107Exp. 09/29/17 Lot# B079Exp. 08/15/17 Lot# B046Exp. 06/01/17
- Amount recalled
- 5,260 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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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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