The Recall Desk
HighFDA (Drugs)·D-0358-2023·Announced 2023-03-08

Injectable Norepinephrine Recalled Nationwide for Sterility Assurance Failure

FDA recalls norepinephrine bitartrate injection (270,291 bottles nationwide) due to lack of sterility assurance. The injectable medication from Nephron Sterile Compounding Center poses infection risk if used.

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 sterile injectable medication with lack of assurance of sterility. While no illnesses or injuries are reported in the source, the product poses significant risk of serious infection if administered. This is a risk-of-harm product where injury has not yet been reported, meeting the Score 3 criterion.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling norepinephrine bitartrate in 0.9% sodium chloride injection (16 mg/250 mL), an intravenous medication used to treat severe low blood pressure in hospital and emergency settings. The recall affects 270,291 bottles in 15-bottle cartons distributed nationwide.

The FDA has classified this as a Class II recall due to lack of assurance of sterility—meaning the injectable product may not meet sterility standards. Non-sterile injectable medications pose a risk of serious infection if administered to patients.

The recall includes 11 lot numbers with expiration dates ranging from February 2023 to September 2023: NB2018A (02/24/2023), NB2022A (03/08/2023), NB2028A (04/04/2023), NB2032A (04/24/2023), NB2036A (05/24/2023), NB2043A (06/17/2023), NB2046A (06/26/2023), NB2049A (07/21/2023), NB2052A (07/27/2023), NB2062A (09/13/2023), and NB2068A (09/23/2023).

Healthcare facilities that received affected products should immediately discontinue use and follow their facility's recall procedures. Patients should consult with their healthcare provider if they have questions about medications they received.

The recalled product

Product
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25.
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable Medication
Hazard
  • sterility-failure
  • infection-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)

  • Lots: NB2018A
  • Exp. 02/24/2023
  • NB2022A
  • Exp. 03/08/2023
  • NB2028A
  • Exp. 04/04/2023
  • NB2032A
  • Exp. 04/24/2023
  • NB2036A
  • Exp. 05/24/2023
  • NB2043A
  • Exp. 06/17/2023
  • NB2046A
  • Exp. 06/26/2023
  • NB2049A
  • Exp. 07/21/2023
  • NB2052A
  • Exp. 07/27/2023
  • NB2062A
  • Exp. 09/13/2023

Distribution

Distributed nationwide across the United States.

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