Agency classClass IIOur severity:High FDA (Drugs)·D-0356-2023·Announced 2023-03-08

Norepinephrine Injection Recalled for Lack of Sterility Assurance

Nephron Sterile Compounding Center is recalling 443,483 bottles of Norepinephrine Bitartrate injection nationwide due to lack of sterility assurance in the product.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Classified as FDA Class II. No illnesses or injuries reported, and the hazard is theoretical (lack of assurance) rather than confirmed contamination. However, lack of sterility in an injectable medication poses serious infection risk, justifying High severity.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP (8 mg/250 mL concentration, 250 mL single-dose containers).

The FDA classified this as a Class II recall due to lack of assurance of sterility in the product. Norepinephrine is a critical injectable medication used to treat low blood pressure in emergency and intensive care settings.

Approximately 443,483 bottles distributed nationwide are affected. The recalled lot numbers span from NB2015A (expiring 02/27/2023) through NB2061A (expiring 09/14/2023), representing 18 specific product lots.

The recalling firm is Nephron Sterile Compounding Center LLC, a 503B outsourcing facility located at 4500 12th Street Extension, West Columbia, SC 29172 (NDC 69374-316-25).

The recalled product

Product: Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25.
Manufacturer: Nephron Sterile Compounding Center LLC
Category: Drug — Injectable Medication
Hazard: lack-of-sterility
infection-risk
Affected units: 443,483

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 (20)

Lots: NB2015A
Exp. 02/27/2023
NB2016A
Exp. 02/19/2023
NB2021A
Exp. 03/05/2023
NB2023A
Exp. 03/12/2023
NB2026A
Exp. 03/29/2023
NB2029A
Exp. 04/21/2023
NB2031A
NB2033A
Exp. 05/10/2023
NB2034A
Exp. 05/19/2023
NB2037A
Exp. 05/25/2023
NB2039A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Nephron Sterile Compounding Center 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 8 products in this recall →

Same manufacturer · Nephron Sterile Compounding Center LLC

See all →

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Same hazard · lack of sterility