FDA Drug recall D-0356-2023

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…

FDA Drug
Class II
terminated
Published 2023-03-08

On 2023-03-08 the FDA classified a Class II recall of 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… by Nephron Sterile Compounding Center, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0356-2023
Classification	Class II
Status	terminated
Initiated	2023-02-22
Published	2023-03-08
Last updated	2026-09-13 11:52 UTC
Company	Nephron Sterile Compounding Center
Distribution	US

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

Identifiers

code_info	Lots: NB2015A, Exp. 02/27/2023; NB2016A, Exp. 02/19/2023; NB2021A, Exp. 03/05/2023; NB2023A, Exp. 03/12/2023; NB2026A,… 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

code_info

Lots: NB2015A, Exp. 02/27/2023; NB2016A, Exp. 02/19/2023; NB2021A, Exp. 03/05/2023; NB2023A, Exp. 03/12/2023; NB2026A,…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0356-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.