Fresenius Kabi USA, LLC recalls Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162…

Recall date

April 20, 2020

Source

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

Recall number

D-1297-2020

FDA classification

Class II

Brand / firm

Fresenius Kabi USA, LLC

Sold / distributed

USA Nationwide and Puerto Rico

Why it was recalled

Presence of Particulate Matter - found in reserve sample vials at the firm.

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 per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.