Vehicle Safety Product Safety Food Safety Pet Safety Drug Safety Device Safety Workplace Safety Bridge Safety Aviation Safety Dam Safety Nursing Homes Water Safety Railroad Safety Pipeline Safety Environmental

ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Ve...

FDA Recall #D-0983-2016 — Class II — May 17, 2016

Recall #D-0983-2016 Date: May 17, 2016 Classification: Class II Status: Terminated

Product Description

ESTRADIOL VALERATE 20MG/ML, packaged in 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.

Recalling Firm

Well Care Compounding Pharmacy — Las Vegas, NV

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

869 Units (Total All Products)

Distribution

NV

Code Information

Lot #: 04112016:76@67, Exp.07/12/2016

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

Back to All Drug Recalls