FDA Recalls NDC 63323-161 Ketorolac Tromethamine
Injection, Solution Intramuscular; Intravenous

FDA Recalls Enforcement Reports

The last Recall Enforcement Report for Ketorolac Tromethamine with NDC 63323-161 was initiated on 12-23-2020 as a Class I recall due to presence of particulate matter - found in reserve sample vials at the firm. The latest recall number for this product is D-0245-2021 and the recall is currently ongoing .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0245-202112-23-202002-03-2021Class I945,425 vialsKetorolac 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.Ongoing
D-0184-202112-17-202001-06-2021Class II490,633 vialsKetorolac 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 63323-162-02Ongoing
D-1296-202004-20-202006-17-2020Class I5,314,400 vialsKetorolac 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.Ongoing
D-1297-202004-20-202006-17-2020Class II3,497,575 vialsKetorolac 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.Ongoing

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.