FDA recall D-0100-2024

Product

4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24

Reason for recall

Presence of Particulate Matter: identified as glass.

Distribution

Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.

Key facts

Status

Terminated

Initiation date

2023-10-02

Report date

2023-11-15

Termination date

2025-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0100-2024