SterRx Norepinephrine Injection Recalled Due to Sterility Assurance Concerns
SterRx is recalling 9,360 bags of Norepinephrine 4 mg per 250 mL injection nationwide due to lack of assurance of sterility. The product is used in hospital and clinical settings to treat low blood pressure.
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 critical-care injectable drug with a fundamental sterility defect. Loss of sterility assurance in parenteral products poses serious risk of infection and complications in vulnerable patients, meeting the Severe threshold even absent reported illnesses.
Plain-English summary
SterRx, LLC is recalling 9,360 bags of Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, NDC 70324-451-01, distributed nationwide in the U.S.A. The recall was issued because the manufacturer cannot assure the sterility of the product.
The affected product was distributed under lot/batch codes S21192/BUV (18-Apr-22), S21205/BVH (23-Apr-22), and S21402/CCK (21-Aug-22). Norepinephrine is a prescription medication administered intravenously to treat critically low blood pressure in hospital and clinical settings.
Patients and healthcare providers who have received this product should not use it. Healthcare facilities should quarantine remaining inventory and consult with their pharmacy and medical staff regarding appropriate patient management. Questions about this recall can be directed to SterRx, LLC, located at 141 Idaho Ave., Plattsburgh, NY 12903.
The recalled product
- Product
- NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-451-01.
- Manufacturer
- SterRx, LLC
- Category
- Drug — Injectable / Parenteral
- Affected units
- 9,360
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 (1)
- S21192/BUV 18-Apr-22 S21205/BVH 23-Apr-22 S21402/CCK 21-Aug-22
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.
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