SterRx Norepinephrine 8 mg Sodium Chloride Injection Recalled
SterRx, LLC is recalling 74,508 bags of Norepinephrine 8 mg per 250 mL in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
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: The FDA classified this as a Class II recall involving a sterile injectable drug product with a critical manufacturing defect (lack of sterility assurance). This type of defect in an injectable medication poses serious risk of systemic infection and meets the Severe classification criterion for FDA Class II recalls with significant harm risk.
Plain-English summary
SterRx, LLC is recalling Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride Injection, distributed nationwide. The product is a prescription-only injectable medication. A total of 74,508 bags across multiple lot codes are affected.
The recall is due to lack of assurance of sterility. This means the manufacturer cannot confirm that the affected units meet required sterility standards for injectable medications.
Consumers and healthcare providers who have received or dispensed these products should not use them. Patients currently receiving this medication should consult their healthcare provider immediately. The affected lot codes are identified in the FDA recall notice and span from November 2021 through April 2022.
The recalled product
- Product
- NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01.
- Manufacturer
- SterRx, LLC
- Affected units
- 74,508
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 →Related recalls
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