Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dos...
FDA Recall #D-0184-2021 — Class II — December 17, 2020
Product Description
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
Reason for Recall
Presence of Particulate Matter - found in reserve sample vials at the firm.
Recalling Firm
Fresenius Kabi USA, LLC — Lake Zurich, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
490,633 vials
Distribution
USA Nationwide and Puerto Rico
Code Information
Batch # 6121125, Exp 02/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated