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.
Reason for recall: Presence of Particulate Matter - found in reserve sample vials at the firm.
Recall initiated: 20201223
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated