Hospira Inc., A Pfizer Company recalls Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only,…

Recall date

August 4, 2016

Source

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

Recall number

D-0218-2017

FDA classification

Class I

Brand / firm

Hospira Inc., A Pfizer Company

Sold / distributed

Nationwide

Why it was recalled

Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.

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 (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02