Drug Enforcement D-0358-2023

Lack of Assurance of Sterility

Status

Terminated

Classification

Class II

Report Date

March 8, 2023

Termination Date

September 24, 2024

Product Information

Product description
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.
Product quantity
270,291 bottles
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Nephron Sterile Compounding Center LLC
Address
4500 12th Street Ext, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0358-2023
Event ID
91749
Recall initiation date
February 22, 2023
Center classification date
February 27, 2023
Code info
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
More code info
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