Drug Enforcement D-0360-2023

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, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL 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 69374-305-10.
Product quantity
31,500 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-0360-2023
Event ID
91749
Recall initiation date
February 22, 2023
Center classification date
February 27, 2023
Code info
Lots: PE2028, Exp. 06/15/2023
More code info
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