TESTOSTERONE CYPIONATE 200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy ...
FDA Recall #D-1015-2016 — Class II — May 17, 2016
Product Description
TESTOSTERONE CYPIONATE 200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV
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 #: 01142016:19@26, Exp. 04/14/2016; Lot #: 02032016:23@32, Exp. 05/05/2016, Lot #: 02092016:17@9, Exp.06/10/2016; Lot #: 04262016: 11@16, Exp. 07/27/2016; Lot #: 01112016:65@70, Exp.04/10/2016; Lot #: 01202016:57@46, Exp.04/19/2016; 01212016:08@34, Exp. 04/28/2016; Lot: 02082016:08@27, Exp.05/08/2016; Lot #: 02222016:82@50, Exp.05/22/2016 03142016:75@24, Exp. 06/14/2016; Lot #: 03212016:07@73, Exp. 06/26/2016 03232016:47@23, Exp. 06/28/2016; Lot #: 04062016:96@28, Exp. 07/06/2016 04132016:@46 , Exp. 07/13/2016; Lot #: 04192016:92@1, Exp.07/19/2016 04272016:63@11, Exp.07/26/2016.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated