Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 6332...
FDA Recall #D-0245-2021 — Class I — December 23, 2020
Product Description
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.
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 I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
945,425 vials
Distribution
Nationwide USA and Puerto Rico
Code Information
Lot # 6121083, Exp 2/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated