Hospira Inc. recalls Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol…

Recall date

December 23, 2014

Source

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

Recall number

D-0381-2015

FDA classification

Class II

Brand / firm

Hospira Inc.

Sold / distributed

Nationwide

Why it was recalled

Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.

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

What was recalled

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30