Ketorolac Tromethamine Injection
FDA Recall NDC 0487-6232
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ketorolac Tromethamine (NDC 0487-6232). A significant event, classified as Class II, was initiated on Aug 10, 2022 by Nephron Pharmaceuticals Corporation. The reported reason for this action was: "cGMP Deviations: deviations leading to potential cross-contamination."
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
cGMP Deviations: deviations leading to potential cross-contamination.
Aug 10, 2022
Aug 24, 2022
5040 vials
Recall Profile & Regulatory Data
Event ID
90703
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Nephron Sc Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Sep 24, 2024
Product Description
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
Batch or Lot Expiration Information
Lot# : 023011 Exp 8/31/2022
Affected Packages Involved in this Recall
0487-6232-01Product
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.
