US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 23, 2023 (4 years ago)

Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Potential product carryover.

What was recalled

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

Recalling firm
Nephron Sc Inc
NDC code
0487-6105-01
Origin
SC, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0364-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.