FDAClass IIJuly 25, 2018

NORepiNEPHrine4mg recall: Sterility Concern

NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL) Volume: 254 mL Single dose…

Why was NORepiNEPHrine4mg recalled?

Lack of Assurance of Sterility: Potential leakage of bags.

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 #: 4/30/18 2471 80725P, BUD 6/29/2018; 5/1/18 1240 80725P, BUD 6/30/2018; 5/8/18 1111 80725P BUD 7/7/2018.

Product
NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL) Volume: 254 mL Single dose…
Recalling firm
Avella of Deer Valley, Inc. Store 38
Quantity
2280 bags
Distribution
Nationwide in the USA
Recall date
July 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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