February 05, 2021
Fresenius Kabi USA has expanded its ketorolac tromethamine injection recall to include nearly 1 million vials of ketorolac tromethamine injection, 30 mg per mL. According to the February 3, 2021, US Food and Drug Administration (FDA) Enforcement Report, the latest recall is designated Class I. The classification warns that use of the affected product could cause serious adverse health consequences or death.
Citing particulate matter discovered in reserve sample vials, the firm is recalling ketorolac tromethamine injection, 30 mg per mL, packaged in 1-mL single-dose vials (vial NDC 63323-162-00; 25-vial tray NDC 63323-162-01) from lot 6121083 (Exp 2/21). The vials were distributed throughout the United States and in Puerto Rico.
Fresenius Kabi USA voluntarily initiated the recall December 23, 2020. On January 27, 2021, the FDA issued the Class I designation.
Ketorolac is a prescription-strength nonsteroidal anti-inflammatory drug used for the short-term relief of moderate to severe pain.