AuroMedics Pharma LLC recalls Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for:…

Recall date

November 12, 2019

Source

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

Recall number

D-0609-2020

FDA classification

Class II

Brand / firm

AuroMedics Pharma LLC

Sold / distributed

Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.

Why it was recalled

Discoloration; Hazy solution found in one vial instead of a clear solution.

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

What was recalled

Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ