FDA recall D-0234-2024

Product

8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-24 (carton), 0409-6637-14 (case).

Reason for recall

Presence of Particulate Matter; identified as glass

Distribution

Nationwide in the USA and Puerto Rico.

Key facts

Status

Ongoing

Initiation date

2023-12-21

Report date

2024-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0234-2024