News | Antiplatelet and Anticoagulation Therapies | January 19, 2018

International Laboratories Recalls Clopidogrel Tablets USP 75 MG

Company initiated voluntary recall for a particular lot due to mislabeling

January 19, 2018 — The U.S. Food and Drug Administration (FDA) announced that International Laboratories LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel Tablets USP, 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.

Clopidogrel Tablets USP 75 mg are a platelet inhibitor (blood thinner) indicated for use in patients with acute coronary syndrome, recent myocardial infarction (MI), recent stroke or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke.

The product was distributed nationwide and delivered to the distribution centers in Arkansas, Georgia, Indiana, California and Maryland, and distributed to retail stores in all U.S. states.

International Laboratories LLC is notifying distributors and customers by letter and is arranging for return of all recalled products. Consumers who have purchased this product should stop using and return the product to the location of purchase for a full refund. For questions regarding return of product call Inmar at 855-258-7280 or via email [email protected] or by using mailing address Recall Coordinator, 635 Vine St., Winston Salem, NC 27101. Inmar’s business hours are Monday – Friday 9 a.m. – 5 p.m. EST.

Consumers should also contact their physician or healthcare provider if they are experiencing any health concerns that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening. Patients should not stop taking clopidogrel without talking to their prescribing physician. Additionally, unintentional consumption of simvastatin could include the common side effects associated with its use and may cause fetal harm when administered to a pregnant woman. Simvastatin occasionally causes myopathy which is a disease of the muscles. Finally, allergic reactions are also possible and could also be life threatening.

For more information: www.fda.gov

 

Related Content

Xarelto Reduces Ischemic Stroke for Coronary and Peripheral Artery Disease Patients
News | Antiplatelet and Anticoagulation Therapies | February 19, 2018
A late-breaking analysis of the landmark COMPASS study was presented at the 2018 International Stroke Conference (ISC...
Abbott Begins Enrollment in XIENCE 28 GLOBAL DAPT Trial
News | Antiplatelet and Anticoagulation Therapies | February 13, 2018
Abbott announced the first patient has been enrolled in a clinical trial evaluating 28 days of dual antiplatelet...
Baxter Announces FDA Approval of Ready-to-Use Cardiovascular Medication Bivalirudin
Technology | Antiplatelet and Anticoagulation Therapies | January 22, 2018
January 22, 2018 — Baxter International Inc. announced the U.S.
New Oral Anticoagulant Drugs Associated with Lower Kidney Risks
News | Antiplatelet and Anticoagulation Therapies | December 12, 2017
Mayo Clinic researchers have shown a link between which type of oral anticoagulant a patient takes to prevent a stroke...
News | Antiplatelet and Anticoagulation Therapies | November 16, 2017
Bristol-Myers Squibb Company and Pfizer Inc. released real-world data (RWD) of outcomes associated with direct oral...
Six Months of DAPT Non-Inferior to Twelve in STEMI Patients Receiving Drug-Eluting Stents
News | Antiplatelet and Anticoagulation Therapies | November 06, 2017
November 6, 2017 —  The first trial to evaluate the safety of...
Statins Attributed With 10-Year Cholesterol Drop for Malaysian Heart Attack Patients
News | Antiplatelet and Anticoagulation Therapies | November 03, 2017
November 3, 2017 — A ten-year decline in the blood cholesterol of heart attack patients in Malaysia suggests...
COMPASS Trial Shows Rivaroxaban With Aspirin Improves Stable Cardiovascular Disease
Feature | Antiplatelet and Anticoagulation Therapies | September 12, 2017
September 12, 2017 — Rivaroxaban plus aspirin improves survival and reduces stroke and heart attack in patients with
Real-World Analysis Compares Safety, Effectiveness of Apixaban Versus Warfarin
News | Antiplatelet and Anticoagulation Therapies | August 28, 2017
August 28, 2017 — Bristol-Myers Squibb Company and Pfizer Inc.
Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies | August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Overlay Init