FDAFDA · Food and drugs·Recall number D-0227-2019
Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
Published November 14, 2018 · Recall initiated: October 17, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Qualgen, LLC
- Distributor
- Nationwide.
- Lot
- Lots: C253 BUD: 12/12/2018; D016 BUD: 1/18/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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