The Recall Desk
HighFDA (Drugs)·D-0357-2023·Announced 2023-03-08

FDA Recalls Norepinephrine Injection Due to Sterility Concerns

Nephron Sterile Compounding Center is recalling Norepinephrine Bitartrate injection nationwide due to lack of sterility assurance. The recall affects 305,895 bottles across 13 lots.

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 for lack of sterility assurance in an injectable pharmaceutical product. The hazard is substantial—potential microbial contamination in injectable medication—but is classified as High rather than Severe because the recall notice does not document hospitalizations, serious injuries, or reported illnesses.

Plain-English summary

Nephron Sterile Compounding Center LLC has recalled Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP (4 mg/250 mL). The product is supplied as single-dose bottles packaged 15 per carton and distributed nationwide. This Class II recall involves 305,895 bottles.

The FDA initiated the recall due to lack of assurance of sterility. Injectable medications must meet strict sterility standards to prevent microbial contamination. The manufacturer could not guarantee that the affected product met these critical standards.

The affected lots are: NB2017A (Exp. 03/04/2023), NB2019A (Exp. 02/21/2023), NB2024A (Exp. 03/27/2023), NB2025A (Exp. 03/24/2023), NB2027A (Exp. 04/07/2023), NB2035A (Exp. 05/22/2023), NB2038A (Exp. 06/02/2023), NB2045A (Exp. 06/25/2023), NB2053A (Exp. 07/29/2023), NB2058B (Exp. 08/16/2023), NB2064A (Exp. 09/07/2023), NB2069A (Exp. 09/25/2023), and NB2071A (Exp. 10/01/2023).

The recalled product

Product
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 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 69374-319-25.
Manufacturer
Nephron Sterile Compounding Center LLC
Category
Drug — Injectable / Sterile Compounded
Hazard
  • microbial-contamination

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: NB2017A
  • Exp. 03/04/2023
  • NB2019A
  • Exp. 02/21/2023
  • NB2024A
  • Exp. 03/27/2023
  • NB2025A
  • Exp. 03/24/2023
  • NB2027A
  • Exp. 04/07/2023
  • NB2035A
  • Exp. 05/22/20123
  • NB2038A
  • Exp. 06/02/2023
  • NB2045A
  • Exp. 06/25/2023
  • NB2053A
  • Exp. 07/29/2023
  • NB2058B
  • Exp. 08/16/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category