Agency classClass IIOur severity:High FDA (Drugs)·D-0934-2023·Announced 2023-07-26

Norepinephrine Injectable Recalled Due to Lack of Sterility Assurance

SterRx recalled 2,088 bags of Norepinephrine 32 mg per 250 mL (Lot #490100) distributed nationwide due to lack of sterility assurance. The recall affects a critical care medication used in intensive care settings.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a sterile injectable product due to lack of sterility assurance. No illnesses or injuries have been reported in the source. The hazard is theoretical rather than confirmed contamination, but the product is a critical care medication where sterility failure poses significant risk of harm.

Plain-English summary

SterRx, LLC has recalled 2,088 bags of Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, Single Dose bags (Lot #490100, expiration date July 27, 2023). The product was distributed nationwide in the United States.

The recall was issued due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the product meets sterility standards. Norepinephrine is a critical care medication administered intravenously to support blood pressure in patients, typically in intensive care environments.

Healthcare facilities and providers should immediately stop using the affected product and verify their inventory for Lot #490100. Any units with this lot number should not be used.

For additional information, healthcare professionals should contact the FDA or SterRx, LLC directly.

The recalled product

Product: Norepinephrine 32 mg per 250 mL (128 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 70324-702-01.
Manufacturer: SterRx, LLC
Category: Drug — Injectable / Critical Care
Hazard: lack-of-sterility
Affected units: 2,088

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot #: 490100
Exp 27-Jul-23

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by SterRx, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · SterRx, LLC

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Same hazard · lack of sterility