Tri-Mix Super Injectable 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 Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Recall number

D-1720-2015

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

Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN