Recall archive / FDA drug enforcement

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Contai... — FDA record D-0356-2023

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, 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.
Reason: Lack of Assurance of Sterility
Classification: Class II
Recalling firm: Nephron Sterile Compounding Center LLC
Quantity: 443,483 bottles
Agency-reported status: Terminated
Source record identifier: D-0356-2023

Open the official record

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: 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, Exp. 04/21/2023; NB2033A, Exp. 05/10/2023; NB2034A, Exp. 05/19/2023; NB2037A, Exp. 05/25/2023; NB2039A, Exp. 06/05/2023; NB2041A, Exp. 06/14/2023; NB2044A, Exp. 06/18/2023; NB2050A, Exp. 07/19/2023; NB2054A, Exp. 08/04/2023; NB2057A, Exp. 08/12/2023; NB2059A, Exp. 08/20/2023; NB2061A, Exp. 09/14/2023; NB2067A, Exp. 09/22/2023

Label field

Details supplied by the agency

Lot, code or applicability

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, Exp. 04/21/2023; NB2033A, Exp. 05/10/2023; NB2034A, Exp. 05/19/2023; NB2037A, Exp. 05/25/2023; NB2039A, Exp. 06/05/2023; NB2041A, Exp. 06/14/2023; NB2044A, Exp. 06/18/2023; NB2050A, Exp. 07/19/2023; NB2054A, Exp. 08/04/2023; NB2057A, Exp. 08/12/2023; NB2059A, Exp. 08/20/2023; NB2061A, Exp. 09/14/2023; NB2067A, Exp. 09/22/2023

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.

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.