FDAClass IIJuly 26, 2023

Norepinephrine 8 mg per recall: Sterility Concern

Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.

Why was Norepinephrine 8 mg per 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 #: 490071, Exp 30-Jul-23; 490089, Exp 4-Aug-23; 490118, 490126, Exp 5-Aug-23; 490169, Exp 10-Aug-23; 491276, Exp 11-Aug-23; 491284, Exp 12-Aug-23; 491612, Exp 18-Aug-23; 497467, Exp 8-Dec-23; 497475, Exp 9-Dec-23; 499104, Exp 18-Jan-24; 499112, Exp 19-Jan-24; 499121, 499278, Exp 20-Jan-24; 499358, Exp 21-Jan-24; 502019, Exp 24-Mar-24; 502027, Exp 29-Mar-24; 502035, Exp 5-Apr-24; 503513, Exp 18-Apr-24; 504217, Exp 20-Apr-24

Product
Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.
Recalling firm
SterRx, LLC
Quantity
125,598 bags
Distribution
Nationwide in the USA
Recall date
July 26, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls