Agency classClass IIOur severity:Severe FDA (Drugs)·D-0320-2022·Announced 2022-01-05

SterRx Norepinephrine Injection Recalled Due to Lack of Sterility Assurance

SterRx is recalling 121,584 bags of Norepinephrine 4 mg per 250 mL injection nationwide due to lack of assurance of sterility. The drug is used to treat low blood pressure in critical 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug used in critical care. Lack of sterility assurance in a parenteral medication poses significant risk of serious infection to vulnerable patients, meeting the Severe criteria for potential hospitalization risk even though no specific illnesses are reported in the source text.

Plain-English summary

SterRx, LLC is recalling Norepinephrine 4 mg per 250 mL (18 mcg per mL) in 0.9% Sodium Chloride Injection (NDC 70324-651-01) because the manufacturer cannot assure the sterility of the product. Approximately 121,584 bags have been distributed nationwide. The affected lots were produced between November 2021 and September 2022.

Norepinephrine is a critical-care drug used to treat patients with dangerously low blood pressure. If the product is not sterile, patients could be exposed to contamination, which could cause serious infection or other adverse health effects in vulnerable populations.

Patients currently taking this medication should not stop treatment without consulting their healthcare provider. Healthcare facilities that received affected lots should quarantine the product and contact their suppliers for replacement stock. Consumers and healthcare providers should report any adverse events to the FDA at 1-888-SAFEFDA or online at www.fda.gov/medwatch.

The recalled product

Product: NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-651-01.
Manufacturer: SterRx, LLC
Category: Drug — Injectable / Critical Care
Hazard: sterility-assurance
contamination-risk
infection-risk
Affected units: 121,584

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 26 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 26 products in this recall →

Same manufacturer · SterRx, LLC

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Norepinephrine Injectable Recalled Due to Lack of Sterility Assurance
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Norepinephrine injectable medication recalled nationwide for sterility assurance
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Same hazard · sterility assurance