FDA-Drug2017-06-21Class II

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

Hospira Inc., A Pfizer Company
Hazard

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

Sold states
Nationwide, Canada and Singapore
Affected count
(720503A): 43,200 vials, (720603A): 400 vials
Manufactured in
275 N Field Dr, N/A, Lake Forest, IL, United States
Products
Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04

Official notice

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

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