Ketorolac Tromethamine Injection, Solution
FDA Recall NDC 63323-162
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Ketorolac Tromethamine (NDC 63323-162). A significant event, classified as Class I, was initiated on Dec 23, 2020 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Presence of Particulate Matter - found in reserve sample vials at the firm."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
December 2020 Class I Recall: Presence of Particulate Matter - found in reserve sample vials at the firm.
Recall Number
Class I Terminated
Presence of Particulate Matter - found in reserve sample vials at the firm.
Dec 23, 2020
Feb 03, 2021
945,425 vials
Recall Profile & Regulatory Data
Event ID
87082
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Puerto Rico
Termination Date
Jun 09, 2023
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.
Batch or Lot Expiration Information
Lot# 6121083, Exp 2/2021
Affected Packages Involved in this Recall
63323-161-00Product
63323-161-01Product
63323-162-11Product
63323-162-51Product
63323-162-00Product
63323-162-01Product
63323-162-03Product
63323-162-02Product
December 2020 Class II Recall: Presence of Particulate Matter - found in reserve sample vials at the firm.
Recall Number
Class II Terminated
Presence of Particulate Matter - found in reserve sample vials at the firm.
Dec 17, 2020
Jan 06, 2021
490,633 vials
Recall Profile & Regulatory Data
Event ID
87005
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide and Puerto Rico
Termination Date
Jun 20, 2023
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
Batch or Lot Expiration Information
Batch# 6121125, Exp 02/2021
Affected Packages Involved in this Recall
63323-161-00Product
63323-161-01Product
63323-162-11Product
63323-162-51Product
63323-162-00Product
63323-162-01Product
63323-162-03Product
63323-162-02Product
April 2020 Class II Recall: Presence of Particulate Matter - found in reserve sample vials at the firm.
Recall Number
Class II Terminated
Presence of Particulate Matter - found in reserve sample vials at the firm.
Apr 20, 2020
Jun 17, 2020
3,497,575 vials
Recall Profile & Regulatory Data
Event ID
85504
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide and Puerto Rico
Termination Date
Oct 16, 2023
Product Description
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Batch or Lot Expiration Information
Lot# : 6119229, 6119273, Exp 06/2020; 6119843, Exp 09/2020; 6121115, Exp 02/2021; 6121451, 6121452, 6121496, Exp 03/2021
Affected Packages Involved in this Recall
63323-161-00Product
63323-161-01Product
63323-162-11Product
63323-162-51Product
63323-162-00Product
63323-162-01Product
63323-162-03Product
63323-162-02Product
April 2020 Class I Recall: Presence of Particulate Matter - found in reserve sample vials at the firm.
Recall Number
Class I Terminated
Presence of Particulate Matter - found in reserve sample vials at the firm.
Apr 20, 2020
Jun 17, 2020
5,314,400 vials
Recall Profile & Regulatory Data
Event ID
85504
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide and Puerto Rico
Termination Date
Oct 16, 2023
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.
Batch or Lot Expiration Information
Lot# : 6118737, 6118902, Exp 04/2020; 6119052, Exp 05/2020; 6119752, Exp 08/2020; 6122349, Exp 07/2021; 6122538, Exp 09/2021
Affected Packages Involved in this Recall
63323-161-00Product
63323-161-01Product
63323-162-11Product
63323-162-51Product
63323-162-00Product
63323-162-01Product
63323-162-03Product
63323-162-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
