TESTOSTERONE CYPIONATE 10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy L...
FDA Recall #D-1012-2016 — Class II — May 17, 2016
Product Description
TESTOSTERONE CYPIONATE 10MG/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 #: 02032016: 60@27, Exp. 05/03/2016; Lot #: 02222016: 29@62, Exp. 05/22/2016; Lot #: 03072016:87@66, Exp.06/06/2016; Lot #: 4152016:34@39, Exp. 07/18/2016; Lot #: 04282016:06@14, Exp. 07/27/2016.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated