Drug Enforcement D-0178-2023

CGMP Deviations: potential for trace amounts of product carryover.

Status

Terminated

Classification

Class II

Report Date

February 1, 2023

Termination Date

October 11, 2024

Product Information

Product description
Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3.
Product quantity
389,730 vials
Reason for recall
CGMP Deviations: potential for trace amounts of product carryover.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Nephron Sc Inc
Address
4500 12th Street Ext, N/A

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

Codes & Dates

Recall number
D-0178-2023
Event ID
91449
Recall initiation date
January 12, 2023
Center classification date
January 24, 2023
Code info
Lots: 124081, 124082, Exp. 04/2023; 224031, Exp. 01/2024
More code info
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