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Recall Observatory FDA recall evidence

Drug product

ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0982-2016

May 17, 2016

Class II

Product summary

Firm
Well Care Compounding Pharmacy
Event
Event 74187
Status
Terminated
Classification
Class II
Quantity
869 Units (Total All Products)
Official record key
drug-enforcement:D-0982-2016

Official wording

Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information: Lot #: 02022016:85@22 , Exp.05/03/2016; Lot #: 02242016:50@16, Exp. 06/12/2016; Lot #:03102016:30@65, Exp. 06/12/2016; Lot #: 3172016:14@19, Exp. 06/15/2016; Lot #: 04122016:20@2 , Exp. 07/11/2016; Lot #: 04212016:84@1, Exp. 07/20/2016.

Distribution pattern: NV

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    GMP violations
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility