TRI-MIX PAPAVERINE 30/PHENTOLAMINE 6/PGE-1 60 INJ INJECTABLE recalled over sterility concerns

Recall date

October 12, 2021

Source

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

Official notice title

Vita Pharmacy, LLC dba Talon Compounding Pharmacy recalls TRI-MIX PAPAVERINE 30/PHENTOLAMINE 6/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks D…

Recall number

D-0224-2022

FDA classification

Class II

Brand / firm

Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Sold / distributed

United States including Washington, D.C. and Puerto Rico

Why it was recalled

Lack of assurance of 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 PAPAVERINE 30/PHENTOLAMINE 6/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247