HOSPIRA INC, LAKE FOREST recalls Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (N…

Recall date

June 4, 2018

Source

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

Recall number

D-0906-2018

FDA classification

Class I

Brand / firm

HOSPIRA INC, LAKE FOREST

Sold / distributed

Nationwide in the U.S., Puerto Rico, and Guam

Why it was recalled

Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.

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

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL