The Recall Desk
HighFDA (Drugs)·D-0933-2023·Announced 2023-07-26

Norepinephrine injectable recalled due to lack of sterility assurance

SterRx is recalling 92,148 bags of norepinephrine injectable due to lack of assurance of sterility. The prescription medication was distributed nationwide.

What this means for you

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: This is an FDA Class II recall of a sterile injectable medication due to lack of assurance of sterility. No illnesses or injuries are reported in the source. As a risk-of-harm product (injectable medication) where injury has not yet been reported, it meets the rubric criterion for High (3).

Plain-English summary

SterRx, LLC is recalling 92,148 bags of Norepinephrine 16 mg per 250 mL in 0.9% Sodium Chloride Single Dose bags. The medication (NDC 70324-602-01) is a prescription injectable.

The recall is due to lack of assurance of sterility. The affected lots did not meet sterility standards, creating a potential risk of contamination if administered.

The recalled medication was distributed nationwide throughout the United States. Sixteen affected lot numbers have been identified, with expiration dates ranging from August 2023 through April 2024. Healthcare providers and hospitals should immediately identify and quarantine any affected lots.

Patients or healthcare providers should consult their physician regarding any doses that may have been received. For the complete list of affected lot numbers and expiration dates, consult the FDA's drug recall website.

The recalled product

Product
Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.
Manufacturer
SterRx, LLC
Category
Drug — Injectable
Hazard
  • sterility-failure
  • contamination-risk

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)

  • Lot #: 490097
  • Exp 3-Aug-23
  • 490142
  • Exp 10-Aug-23
  • 491292
  • Exp 13-Aug-23
  • 494442
  • Exp 26-Nov-23
  • 496763
  • Exp 30-Nov-23
  • 496771
  • Exp 1-Dec-23
  • 497408
  • Exp 2-Dec-23
  • 497416
  • Exp 3-Dec-23
  • 499438
  • Exp 28-Jan-24
  • 501032
  • Exp 8-Feb-24

Distribution

Distributed nationwide across the United States.

Related recalls

Same category