FDA recall D-0136-2020

Product

10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13

Reason for recall

Lack of Assurance of Sterility: Bag has the potential to leak.

Distribution

Nationwide in the United States and Puerto Rico

Key facts

Status

Terminated

Initiation date

2019-10-02

Report date

2019-10-16

Termination date

2020-12-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0136-2020