D-0984-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 15, 2016
- Initiation Date
- May 17, 2016
- Termination Date
- January 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 869 Units (Total All Products)
Product Description
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.
Distribution Pattern
NV
Code Information
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