Norepinephrine IV Bag (SterRx) – Sterility Concern (2023)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.
Brand
SterRx, LLC
Lot Codes / Batch Numbers
Lot #: 490097, Exp 3-Aug-23, 490142, Exp 10-Aug-23, 491292, Exp 13-Aug-23, 494442, Exp 26-Nov-23, 496763, Exp 30-Nov-23, 496771, Exp 1-Dec-23, 497408, Exp 2-Dec-23, 497416, Exp 3-Dec-23, 499438, Exp 28-Jan-24, 501032, Exp 8-Feb-24, 501059, Exp 15-Feb-24, 502043, Exp 28-Mar-24, 502051, Exp 31-Mar-24, 503505, Exp 4-Apr-24, 504031, Exp 7-Apr-24, 504250, Exp 19-Apr-24
Products Sold
Lot #: 490097, Exp 3-Aug-23; 490142, Exp 10-Aug-23; 491292, Exp 13-Aug-23; 494442, Exp 26-Nov-23; 496763, Exp 30-Nov-23; 496771, Exp 1-Dec-23; 497408, Exp 2-Dec-23; 497416, Exp 3-Dec-23; 499438, Exp 28-Jan-24; 501032, Exp 8-Feb-24; 501059, Exp 15-Feb-24; 502043, Exp 28-Mar-24; 502051, Exp 31-Mar-24; 503505, Exp 4-Apr-24; 504031, Exp 7-Apr-24; 504250, Exp 19-Apr-24
SterRx, LLC is recalling Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, pac due to Lack of Assurance of Sterility. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026