FDA recall D-0265-2022

Pfizer Inc. · Class II · drug

Product

5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66

Reason for recall

Lack of sterility assurance: bag has the potential to leak.

Distribution

USA Nationwide

Key facts

Status: Terminated
Initiation date: 2021-11-30
Report date: 2021-12-08
Termination date: 2023-07-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0265-2022