Ketorolac Tromethamine Injection, Solution
FDA Recall NDC 25021-700
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Ketorolac Tromethamine (NDC 25021-700). A significant event, classified as Class II, was initiated on Apr 30, 2019 by Sagent Pharmaceuticals. The reported reason for this action was: "Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products."
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
Class II Terminated
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Apr 30, 2019
May 15, 2019
75,825 vials
Recall Profile & Regulatory Data
Event ID
82741
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sagent Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Puerto Rico
Termination Date
Sep 28, 2020
Product Description
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02
Batch or Lot Expiration Information
Lot# : M813513, Exp. Feb 2020
Affected Packages Involved in this Recall
25021-700-01Product
25021-701-01Product
25021-701-02Product
Class II Terminated
Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
Oct 03, 2014
Oct 22, 2014
69,050 vials
Recall Profile & Regulatory Data
Event ID
69485
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sagent Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Feb 23, 2016
Product Description
Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195
Batch or Lot Expiration Information
Lot# Lot MP5021, Exp. 04/16; Lots MP5024, MP5025, Exp. 05/16
Affected Packages Involved in this Recall
25021-700-01Product
25021-701-01Product
25021-701-02Product
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.
