FDA-Drug2020-06-17Class 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.
Fresenius Kabi USA, LLC
Hazard
Presence of Particulate Matter - found in reserve sample vials at the firm.
Sold states
USA Nationwide and Puerto Rico
Affected count
5,314,400 vials
Manufactured in
3 Corporate Dr, N/A, 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-1296-2020Don't want to check this manually?
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