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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Nephron Sterile Water for Injection Recalled for Manufacturing Deviations

Agency Publication Date: March 1, 2023
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Summary

Nephron Sc Inc is recalling 325,080 vials of Nephron Sterile Water for Injection, USP (5 mL single-dose vials), due to manufacturing deviations that could lead to product carryover. This carryover means residues from previously manufactured products may have entered the water. While no injuries or adverse reactions have been reported to date, this recall is being conducted to ensure patient safety.

Risk

Manufacturing deviations that cause product carryover could potentially contaminate the sterile water with unexpected substances. If injected, contaminated sterile water could cause infections or serious adverse medical reactions.

What You Should Do

  1. This recall affects Nephron brand Sterile Water for Injection, USP, in 5 mL single-dose vials, distributed in cartons containing 30 vials (NDC 0487-6105-01).
  2. Identify affected products by looking for lot numbers 224011, 224021, 224022, or 224023, all with an expiration date of 12/31/2023.
  3. Stop using the recalled product immediately.
  4. Contact the manufacturer or your distributor to arrange for the return of any remaining vials.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance or to report any issues.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Sterile Water for Injection, USP (5 mL)by Nephron
Variants: Single-Dose Vial, Rx Only
Lot Numbers:
224011 (Exp 12/31/2023)
224021 (Exp 12/31/2023)
224022 (Exp 12/31/2023)
224023 (Exp 12/31/2023)
NDC:
0487-6105-01

Recall #: D-0364-2023; Quantity: 325,080 vials; Distributed in 30x5 mL configurations.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91767
Status: Resolved
Manufacturer: Nephron Sc Inc
Sold By: hospitals; clinics; pharmacies
Manufactured In: United States
Units Affected: 325,080 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 ยท 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.