FDAClass IIJuly 25, 2018

NORepiNEPHrine Bitartrate recall: Sterility Concern

NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX…

Why was NORepiNEPHrine Bitartrate 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 #: 5/7/18 0301 2-80761S, BUD 6/21/2018; 5/9/18 0510 2-80761S, BUD 6/23/2018; 5/21/18 1807 80761S, BUD 7/15/2018.

Product
NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX…
Recalling firm
Avella of Deer Valley, Inc. Store 38
Quantity
850 syringes
Distribution
Nationwide in the USA
Recall date
July 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls