Fentanyl Citrate Injection recalled over sterility concerns

Recall date

November 1, 2016

Source

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

Official notice title

Hospira Inc. recalls Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL…

Recall number

D-0153-2017

FDA classification

Class II

Brand / firm

Hospira Inc.

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility: Complaints of broken tips on the ampules.

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

What was recalled

Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32