Sodium Chloride Injection
FDA Recall NDC 0487-4301
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sodium Chloride (NDC 0487-4301). A significant event, classified as Class II, was initiated on Jan 12, 2023 by Nephron Pharmaceuticals Corporation. The reported reason for this action was: "CGMP Deviations: potential for trace amounts of product carryover."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: potential for trace amounts of product carryover.
Jan 12, 2023
Feb 01, 2023
378 bags
Recall Profile & Regulatory Data
Event ID
91449
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Nephron Sc Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Oct 11, 2024
Product Description
0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874 30110 3.
Batch or Lot Expiration Information
Lot# Lot: 271043, Exp. 03/2023
Affected Packages Involved in this Recall
0487-4301-25Product
0487-4301-10Product
0487-4301-05Product
0487-4301-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
