FDA Drug recall D-0358-2023
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged…
- 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, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged… by Nephron Sterile Compounding Center, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0358-2023 |
| 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, 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.
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lots: NB2018A, Exp. 02/24/2023; NB2022A, Exp. 03/08/2023; NB2028A, Exp. 04/04/2023; NB2032A, Exp. 04/24/2023; NB2036A,…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; NB2068A, Exp. 09/23/2023 |
|---|
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-0358-2023%22
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