FDA recall D-0097-2023

Product

Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,

Reason for recall

Lack of assurance of sterility: Bags have the potential to leak.

Distribution

Nationwide in the USA.

Key facts

Status

Completed

Initiation date

2022-12-29

Report date

2023-01-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0097-2023