FDAClass IIJanuary 19, 2022

Norepinephrine Bitartrate Injection USP 4 mg/4 mL recall: Sterility Concern

Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva…

Why was Norepinephrine Bitartrate Injection USP 4 mg/4 mL recalled?

Lack of Assurance of Sterility

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 # 100020800, exp 07/2022

Product
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva…
Recalling firm
Teva Pharmaceuticals USA
Quantity
11,450 vials
Distribution
Methylprednisolone, TN Norepinephrine BItartrate - MS, OH
Recall date
January 19, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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