Tri 1 NR Injectable recalled over sterility concerns

Recall date

September 21, 2016

Source

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

Official notice title

Wells Pharmacy Network LLC recalls Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharm…

Recall number

D-0407-2017

FDA classification

Class II

Brand / firm

Wells Pharmacy Network LLC

Sold / distributed

Nationwide

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 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL