FDAClass IIJuly 11, 2018

Norepinephrine Bitartrate 16 mg recall: Sterility Concern

Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

Why was Norepinephrine Bitartrate 16 mg recalled?

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

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 # 1218000677, 1218000947, 1218000982, 1218001018, 1218001029, 1218001059, 1218001060, 1218001078, 1218001079, 1218001171, 1218001172, 1218001192, 1218001193, 1218001207, 1218001209, 1218001210, Exp 06/19/2018-07/03/2018

Product
Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Recalling firm
SCA Pharmaceuticals, LLC
Quantity
1,397 bags
Distribution
Product was distributed throughout the United States.
Recall date
July 11, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls