FDAClass IISeptember 27, 2017

Levophed recall: Sterility Concern

Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake…

Why was Levophed recalled?

Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.

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?

Lot #: 753003A, Exp 9/18; 762153A, 760803A, 761053A , Exp 10/18

Product
Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake…
Recalling firm
Pfizer Inc.
Quantity
98,050 vials
Distribution
United States Nationwide (including Puerto Rico) and Singapore
Recall date
September 27, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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