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D-0364-2023 Class II Terminated

Recalled by Nephron Sc Inc — West Columbia, SC

FDA drug recall D-0364-2023 was initiated by Nephron Sc Inc on Feb 23, 2023 and is designated Class II. Reason for recall: CGMP Deviations: Potential product carryover. The recall status is terminated (terminated Oct 11, 2024). Affected quantity: 325,080 vials.

Recall Details

Product Type: Drugs
Report Date: Mar 8, 2023
Initiation Date: Feb 23, 2023
Termination Date: Oct 11, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 325,080 vials

Product Description

Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01

Reason for Recall

CGMP Deviations: Potential product carryover.

Distribution Pattern

United States

Code Information

Lot #: 224011, 224021, 224022, 224023 Exp 12/31/2023

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0364-2023
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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