Fresenius Kabi USA, LLC recalls Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL S…

Recall date

April 20, 2020

Source

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

Recall number

D-1296-2020

FDA classification

Class I

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 I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.