MIC/BCOMP+CAR+ARG+CHR+LID 12 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 MIC/BCOMP+CAR+ARG+CHR+LID 12.5 mg/25 mg/25 mg/25 mg/12.5 mg/0.2 mg/20 mg/mL Injectable, a) 10 mL and b) 30 mL vial, Com…

Recall number

D-0371-2017

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

MIC/BCOMP+CAR+ARG+CHR+LID 12.5 mg/25 mg/25 mg/25 mg/12.5 mg/0.2 mg/20 mg/mL Injectable, a) 10 mL and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL