FDA-Drug2021-01-06Class II

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

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
490,633 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0184-2021

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