FDA recall D-0906-2018

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-06-04

Report date

2018-06-13

Termination date

2020-03-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

LAKE FOREST, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0906-2018