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 Si
Recalled February 3, 2021 · FDA recall D-0245-2021 · Fresenius Kabi USA
Hazard
Presence of Particulate Matter - found in reserve sample vials at the firm. · FDA Class I
Units
945,425 vials
Sold at
Nationwide USA and Puerto Rico
Description
Presence of Particulate Matter - found in reserve sample vials at the firm.
Product
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.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →