Drug Enforcement D-0359-2023

Lack of Assurance of Sterility

Status

Terminated

Classification

Class II

Report Date

March 8, 2023

Termination Date

September 24, 2024

Product Information

Product description
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-302-10.
Product quantity
546,450 vials
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-0359-2023
Event ID
91749
Recall initiation date
February 22, 2023
Center classification date
February 27, 2023
Code info
Lots: PE2025, Exp. 05/28/2023; PE2026, Exp. 06/02/2023; PE2027, Exp. 06/04/2023; PE2030, Exp. 06/29/2023; PE2031, Exp. 06/27/2023; PE2032, Exp. 07/09/2023; PE2032A, Exp. 07/09/2023; PE2033, Exp. 08/03/2023; PE2034, Exp. 08/31/2023; PE2035, Exp. 09/11/2023
More code info
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