Sterile Water Injection
FDA Recall NDC 0487-6105
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Sterile Water (NDC 0487-6105). A significant event, classified as Class II, was initiated on Feb 23, 2023 by Nephron Pharmaceuticals Corporation. The reported reason for this action was: "CGMP Deviations: Potential 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 product carryover.
Feb 23, 2023
Mar 08, 2023
325,080 vials
Recall Profile & Regulatory Data
Event ID
91767
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Nephron Sc Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States
Termination Date
Oct 11, 2024
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
Batch or Lot Expiration Information
Lot# : 224011, 224021, 224022, 224023 Exp 12/31/2023
Affected Packages Involved in this Recall
0487-6105-01Product
Class II Terminated
CGMP Deviations: potential for trace amounts of product carryover.
Jan 12, 2023
Feb 01, 2023
389,730 vials
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
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.
Batch or Lot Expiration Information
Lot# Lots: 124081, 124082, Exp. 04/2023; 224031, Exp. 01/2024
Affected Packages Involved in this Recall
0487-6105-01Product
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.
