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TESTOSTERONE CYPIONATE 175MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy ...

FDA Recall #D-1014-2016 — Class II — May 17, 2016

Recall #D-1014-2016 Date: May 17, 2016 Classification: Class II Status: Terminated

Product Description

TESTOSTERONE CYPIONATE 175MG/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 #: 02172016:12@37, Exp. 05/18/2016; Lot #: 03182016: 88@13, Exp. 06/16/2016; Lot #: 04202016:35@14, Exp. 07/19/2016.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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