Hospira Inc. recalls Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC.,…

Recall date

April 23, 2015

Source

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

Recall number

D-1216-2015

FDA classification

Class I

Brand / firm

Hospira Inc.

Sold / distributed

U.S. Nationwide including Guam.

Why it was recalled

Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.