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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- sterility-assurance
- contamination-risk
- infection-risk
Distribution
Distributed nationwide across the United States.
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