FDAFDA · Food and drugs·Recall number D-0984-2016
ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Published June 15, 2016 · Recall initiated: May 17, 2016
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: FDA inspection identified GMP violations potentially impacting product quality and sterility.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Well Care Compounding Pharmacy
- Distributor
- NV
- Lot
- Lot #: 02162016:85@45, Exp. 5/17/2016; Lot #:03092016:30@19, Exp. 06/07/2016; Lot #: 01282016:77@25, Exp.05/03/2016; Lot #: 3112016:98@21, Exp. 06/13/2016; Lot #:03242016:52@22, Exp. 06/27/2016; Lot #: 04122016:15@50, Exp. 7/11/2016
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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