Drug & medication recalls Moderate risk

Sterile Water for Injection recalled over manufacturing violations

Recall date
February 23, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Nephron Sc Inc recalls Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia,…
Recall number
D-0364-2023
FDA classification
Class II
Brand / firm
Nephron Sc Inc
Sold / distributed
United States

Why it was recalled

CGMP Deviations: Potential product carryover.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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

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