Nephron Sc Sterile Water for Injection Recall: FDA Class II

Why it was recalled

CGMP Deviations: Potential product carryover.

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

United States

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0364-2023
Classification: Class II
Status: Terminated
Recall initiated: Feb 23, 2023
FDA report date: Mar 8, 2023
Quantity: 325,080 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Nephron Sc Inc

Original FDA data

Every field from FDA enforcement report D-0364-2023, exactly as published.

Show all FDA fields

City: West Columbia
State: SC
Status: Terminated
Country: United States
Event ID: 91767
Address: 4500 12th Street Ext
Code information: Lot #: 224011, 224021, 224022, 224023 Exp 12/31/2023
Postal code: 29172-3025
Report date: Mar 8, 2023
Product type: Drugs
Recall number: D-0364-2023
Classification: Class II
Recalling firm: Nephron Sc Inc
Product quantity: 325,080 vials
Termination date: Oct 11, 2024
Reason for recall: CGMP Deviations: Potential product carryover.
Voluntary / mandated: Voluntary: Firm initiated
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
Distribution pattern: United States
Recall initiation date: Feb 23, 2023
Initial firm notification: Letter
Center classification date: Mar 1, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0364-2023, published Mar 8, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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Nephron Sc Sterile Water for Injection Recall

Summary