FDAClass IIFebruary 28, 2024

Norepinephrine Bitartrate in 5% Dextrose Injection recall

Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare…

Why was Norepinephrine Bitartrate in 5% Dextrose Injection recalled?

Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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 23I21G64; Exp. 07/31/2024

Product
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare…
Recalling firm
Baxter Healthcare Corporation
Quantity
13,000 bags
Distribution
Nationwide in the USA
Recall date
February 28, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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