FDA Drug Class II — Moderate

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

Hazard

Presence of Particulate Matter - found in reserve sample vials at the firm.

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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
Brand
Fresenius Kabi USA, LLC
UPC
Batch # 6121125, Exp 02/2021

Units Affected

490,633 vials

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