PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 21, 2017 Initiated: May 18, 2017 #D-0898-2017

Product Description

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.

Details

Units Affected
(720503A): 43,200 vials, (720603A): 400 vials
Distribution
Nationwide, Canada and Singapore
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04. Recalled by Hospira Inc., A Pfizer Company. Units affected: (720503A): 43,200 vials, (720603A): 400 vials.
Why was this product recalled?
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 21, 2017. Severity: Moderate. Recall number: D-0898-2017.