Testosterone Cypionate 200 mg/ml Anastrazole 0 recalled over sterility concerns

Recall date

June 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

The Compounding Pharmacy of America recalls Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Cholecalciferol 50,000 U/ml, Injectable, Multi-Dose Vial, Steri…

Recall number

D-1646-2015

FDA classification

Class II

Brand / firm

The Compounding Pharmacy of America

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Cholecalciferol 50,000 U/ml, Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN