January 08, 2021
Particulate matter discovered in reserve sample vials has led Fresenius Kabi USA to recall nearly a half million vials of ketorolac tromethamine injection. The recall was announced in the January 6, 2021, US Food and Drug Administration (FDA) Enforcement Report.
Recalled are 490,633 vials of ketorolac tromethamine injection, 60 mg/2 mL (30 mg/mL), packaged in 2-mL single-dose vials (NDC 63323-162-02) from batch 6121125 (Exp. 2/21). The vials were distributed throughout the United States and in Puerto Rico.
Fresenius Kabi USA voluntarily initiated the recall December 17, 2020. On December 31, 2020, the FDA designated the recall Class II. The classification communicates that use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Ketorolac is a prescription-strength nonsteroidal anti-inflammatory drug used for the short-term relief of moderate to severe pain.