FDA-Drug2021-02-03Class I
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.
Hazard
Presence of Particulate Matter - found in reserve sample vials at the firm.
Sold states
Nationwide USA and Puerto Rico
Affected count
945,425 vials
Manufactured in
3 Corporate Dr, Lake Zurich, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0245-2021More Fresenius Kabi USA, LLC recalls
- FDA-Drug2026-06-17Fresenius Kabi epinephrine injection recalled for failed impurity specifications
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility concerns
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for lack of sterility assurance
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