Fresenius Kabi USA, LLC recalls Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresen
Recalled January 6, 2021 · FDA recall D-0184-2021 · Fresenius Kabi USA
Hazard
Presence of Particulate Matter - found in reserve sample vials at the firm. · FDA Class II
Units
490,633 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 Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →