Recall archive / FDA drug enforcement
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Contai... — FDA record D-0357-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 22, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- Lack of Assurance of Sterility
- Classification
- Class II
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Quantity
- 305,895 bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0357-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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; NB2064A, Exp. 09/07/2023; NB2069A, Exp. 09/25/2023; NB2071A, Exp. 10/01/2023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide in the USA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 8, 2023
- Recall initiation date
- Feb 22, 2023
- Center classification date
- Feb 27, 2023
- Termination date
- Sep 24, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.