Drug Enforcement D-0064-2023

CGMP Deviations: Potential for cross contamination due to product carry over.

Status

Terminated

Classification

Class II

Report Date

November 23, 2022

Termination Date

September 24, 2024

Product Information

Product description
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
Product quantity
34,020 vials
Reason for recall
CGMP Deviations: Potential for cross contamination due to product carry over.
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-0064-2023
Event ID
91132
Recall initiation date
November 10, 2022
Center classification date
November 17, 2022
Code info
Lots: LB2001B Exp. 01/07/2023; LB2005B Exp. 03/02/2023
More code info
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