FDA recall D-0898-2017

Hospira Inc., A Pfizer Company · Class II · drug

Product

Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04

Reason for recall

GMP Deviation; A foreign stopper was observed during packaging of a lot of product.

Distribution

Nationwide, Canada and Singapore

Key facts

Status: Terminated
Initiation date: 2017-05-18
Report date: 2017-06-21
Termination date: 2019-05-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0898-2017