Reported Jun 14, 2017 · Terminated
Estradiol 18 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 18 mg pellet99.5% Estradiol USP.5% Stearic Acid NF in 1 count12 countand 30 count bottlesSterile Office Use OnlySubcutaneous Use OnlyRx Only
- Manufactured byQualgen 14844 Bristol Park Blvd Edmond
- OK 73013 NDC69761-018-01
- Lot codes and dates
Lot# C018Exp. 08/2/17 Lot# B151Exp. 12/7/17 Lot# B108Exp. 10/3/17 Lot# B095Exp. 09/12/17 Lot# B062Exp. 07/6/17 Lot# B035Exp. 05/2/17 Lot# B133Exp. 11/4/17
- Amount recalled
- 6,361 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Qualgen recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.