Product: ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Reason for recall: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated: 20160517
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated