SterRx Norepinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling 1,044 bags of Norepinephrine 16 mg per 250 mL in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product carries NDC 70324-002-01 with lot code S21194/CDW.
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 for a sterile injectable drug. Lack of sterility assurance in intravenous medications poses a significant risk of serious patient harm through infection or sepsis, warranting a Severe classification even though no specific illnesses or hospitalizations are reported in the source text.
Plain-English summary
SterRx, LLC is recalling Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 5% Dextrose Injection, Rx only, due to lack of assurance of sterility. The recall affects 1,044 bags distributed nationwide in the U.S.A. The affected product is identified by NDC 70324-002-01 and lot code S21194/CDW.
Norepinephrine is a critical care medication used intravenously. Lack of sterility assurance in injectable medications poses a risk of infection or contamination when administered to patients.
Patients or healthcare providers in possession of the recalled product should discontinue use and contact their pharmacy or healthcare facility for guidance on replacement or appropriate disposal. Healthcare providers should also check their inventory for the affected lot.
The recalled product
- Product
- NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.
- Manufacturer
- SterRx, LLC
- Affected units
- 1,044
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)
- S21194/CDW
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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