FDAClass IIJune 21, 2017

Levophed norepinephrine bitartrate recall

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

Why was Levophed norepinephrine bitartrate recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

720503A, 720603A (Canada only)

Product
Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04
Recalling firm
Hospira Inc., A Pfizer Company
Quantity
(720503A): 43,200 vials, (720603A): 400 vials
Distribution
Nationwide, Canada and Singapore
Recall date
June 21, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls