Medications & Supplements/Prescription Drugs

Nephron Injectable Saline and Sterile Water Recalled for Product Carryover

Agency Publication Date: January 24, 2023

Summary

Nephron Sc Inc. has recalled approximately 390,108 units of injectable saline and sterile water, including 100 mL bags of Sodium Chloride Injection and 5 mL vials of Sterile Water for Injection. The recall was issued due to manufacturing deviations that created the potential for trace amounts of other products to be carried over into these solutions. No injuries or adverse incidents have been reported to date. These products were distributed nationwide to hospitals, pharmacies, and healthcare facilities.

Risk

The potential for trace amounts of other products to be mixed into these sterile solutions during manufacturing poses a health risk to patients receiving injections. The presence of unintended ingredients could cause adverse reactions or compromise the safety and effectiveness of the medical treatment.

What You Should Do

This recall affects Nephron Pharmaceuticals 0.9% Sodium Chloride Injection (100 mL bags) and Sterile Water for Injection (5 mL vials).
Check the product label for the following identification codes: Sodium Chloride Injection (NDC 0487-4301-10, UPC 304874301103) and Sterile Water for Injection (NDC 0487-6105-01, UPC 304876105013).
Identify affected units by checking the lot numbers on the packaging: saline lot 271043 (Exp. 03/2023); or sterile water lots 124081 (Exp. 04/2023), 124082 (Exp. 04/2023), and 224031 (Exp. 01/2024).
Stop using the recalled product. Contact Nephron Sc Inc or your medical distributor to arrange for the return of any remaining affected stock.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have further questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: 0.9% Sodium Chloride Injection, USP (100 mL Single-Dose Container bag)by Nephron Pharmaceuticals Corporation

Variants: 100 mL Single-Dose Container bag, Rx Only

UPC Codes:

304874301103

Lot Numbers:

271043 (Exp. 03/2023)

NDC:

0487-4301-10

Recall #: D-0177-2023; 378 bags affected.

Product: Sterile Water for Injection, USP, For Drug Diluent Use Only (5 mL Single-Dose Vial)by Nephron Pharmaceuticals Corporation

Variants: 5 mL Single-Dose Vial, 30 x 5 mL Single-Dose Vials per carton, Rx Only

UPC Codes:

304876105013

Lot Numbers:

124081 (Exp. 04/2023)

124082 (Exp. 04/2023)

224031 (Exp. 01/2024)

NDC:

0487-6105-01

Recall #: D-0178-2023; 389,730 vials affected.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91449

Status: Resolved

Manufacturer: Nephron Sc Inc

Sold By: hospitals; pharmacies; healthcare facilities

Manufactured In: United States

Units Affected: 2 products (378 bags; 389,730 vials)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects Nephron Pharmaceuticals 0.9% Sodium Chloride Injection (100 mL bags) and Sterile Water for Injection (5 mL vials).

Check the product label for the following identification codes: Sodium Chloride Injection (NDC 0487-4301-10, UPC 304874301103) and Sterile Water for Injection (NDC 0487-6105-01, UPC 304876105013).

Identify affected units by checking the lot numbers on the packaging: saline lot 271043 (Exp. 03/2023); or sterile water lots 124081 (Exp. 04/2023), 124082 (Exp. 04/2023), and 224031 (Exp. 01/2024).

Stop using the recalled product. Contact Nephron Sc Inc or your medical distributor to arrange for the return of any remaining affected stock.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have further questions regarding this recall.

Affected Products

Product: 0.9% Sodium Chloride Injection, USP (100 mL Single-Dose Container bag)by Nephron Pharmaceuticals Corporation

Variants: 100 mL Single-Dose Container bag, Rx Only

UPC Codes:

304874301103

Lot Numbers:

271043 (Exp. 03/2023)

NDC:

0487-4301-10

Recall #: D-0177-2023; 378 bags affected.

Product: Sterile Water for Injection, USP, For Drug Diluent Use Only (5 mL Single-Dose Vial)by Nephron Pharmaceuticals Corporation

Variants: 5 mL Single-Dose Vial, 30 x 5 mL Single-Dose Vials per carton, Rx Only

UPC Codes:

304876105013

Lot Numbers:

124081 (Exp. 04/2023)

124082 (Exp. 04/2023)

224031 (Exp. 01/2024)

NDC:

0487-6105-01

Recall #: D-0178-2023; 389,730 vials affected.