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-
Recalled June 17, 2020 · FDA recall D-1297-2020 · Fresenius Kabi USA
Hazard
Presence of Particulate Matter - found in reserve sample vials at the firm. · FDA Class II
Units
3,497,575 vials
Sold at
USA Nationwide and Puerto Rico
Description
Presence of Particulate Matter - found in reserve sample vials at the firm.
Product
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.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →