Meloxicam Tablet
FDA Recall NDC 69097-159
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 Meloxicam (NDC 69097-159). A significant event, classified as Class II, was initiated on Jan 26, 2022 by Cipla Usa Inc.. The reported reason for this action was: "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions."
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: Products were exposed to temperatures outside of the products labeled storage conditions.
Jan 26, 2022
Jan 03, 2024
1 unit
Recall Profile & Regulatory Data
Event ID
89450
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CARDINAL HEALTHCARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 29, 2024
Product Description
Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., Kurkumbh, India; Manufactured for: Cipla USA, Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156. NDC: 69097-159-15
Batch or Lot Expiration Information
Batch# Batch KA11489
Affected Packages Involved in this Recall
69097-158-15Product
69097-158-07Product
69097-158-12Product
69097-159-12Product
69097-159-07Product
69097-159-15Product
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
576 bottles
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Meloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactured for: Cipla USA, Inc. 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156
Batch or Lot Expiration Information
Lot# KA03034
Affected Packages Involved in this Recall
69097-158-15Product
69097-158-07Product
69097-158-12Product
69097-159-12Product
69097-159-07Product
69097-159-15Product
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.
