Drug Enforcement D-0065-2023

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-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.
Product quantity
56,220 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-0065-2023
Event ID
91132
Recall initiation date
November 10, 2022
Center classification date
November 17, 2022
Code info
Lots: NE1062A, NE1062B Exp. 12/02/2022; NE1065A, NE1065B Exp. 12/13/2022; NE2011A, NE2011B Exp. 03/15/2022.
More code info
—