FDAClass IIJuly 25, 2018

NORepiNEPHrine 16 recall: Sterility Concern

NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. Volume: 266 mL. Single dose bag. Avella of Houston, 9265…

Why was NORepiNEPHrine 16 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 #:4/26/18 0515 83425P, BUD 6/25/2018; 4/24/18 1332 83425P, BUD 6/23/2018.

Product
NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. Volume: 266 mL. Single dose bag. Avella of Houston, 9265…
Recalling firm
Avella of Deer Valley, Inc. Store 38
Quantity
520 bags
Distribution
Nationwide in the USA
Recall date
July 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls