Ketorolac Tromethamine Injection recalled over manufacturing violations

Recall date

August 10, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Nephron Sc Inc recalls Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharm…

Recall number

D-1354-2022

FDA classification

Class II

Brand / firm

Nephron Sc Inc

Sold / distributed

USA Nationwide

Why it was recalled

cGMP Deviations: deviations leading to potential cross-contamination.

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

What was recalled

Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01