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

Aspirin Should Not Be Recommended for Healthy People Over 70
News | Antiplatelet and Anticoagulation Therapies | September 20, 2019
Low-dose aspirin does not prolong disability-free survival of healthy people over 70, even in those at the highest risk...
Ticagrelor Plus Aspirin Reduces Ischemic Events in Stable Coronary Patients With Diabetes
News | Antiplatelet and Anticoagulation Therapies | September 10, 2019
The combination of ticagrelor and aspirin reduces ischemic events compared with aspirin alone in patients with stable...
Prasugrel Cuts Ischemic Events in Acute Coronary Syndrome Patients
News | Antiplatelet and Anticoagulation Therapies | September 09, 2019
Prasugrel is superior to ticagrelor for reducing ischemic events in patients with acute coronary syndrome and a planned...
Advances in Anticoagulants Expand Options for VTE Prevention, Treatment
News | Antiplatelet and Anticoagulation Therapies | July 26, 2019
A new article published in AACN Advanced Critical Care outlines the traditional anticoagulant therapies familiar to...
Fragmin (dalteparin sodium) injection was cleared by the FDA for use in pediatric patients. It was initially approved by the FDA in 1994 for adults and is a type of heparin.

Fragmin (dalteparin sodium) injection is now cleared by the FDA for use in pediatric patients. It was initially approved by the FDA in 1994 for adults and is a type of heparin.

Technology | Antiplatelet and Anticoagulation Therapies | May 17, 2019
May 17, 2019 — The U.S.
PhaseBio Receives FDA Breakthrough Therapy Designation for Ticagrelor Reversal Agent
Technology | Antiplatelet and Anticoagulation Therapies | April 30, 2019
PhaseBio Pharmaceuticals Inc. announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy...
People With Heart Disease at Risk When Pharmacies Close
News | Antiplatelet and Anticoagulation Therapies | April 24, 2019
April 24, 2019 — New research from the University of Illinois at Chicago shows that when pharmacies close, people sto
Study Finds Only Six Percent of Patients Taking Statins as Directed
News | Antiplatelet and Anticoagulation Therapies | April 18, 2019
A recent study found patients with atherosclerotic cardiovascular disease cut their risk of a second major adverse...
HonorHealth Research Institute Launches SynIVUS-DAPT Study
News | Antiplatelet and Anticoagulation Therapies | April 16, 2019
HonorHealth Research Institute announced the first patients have been enrolled in the SynIVUS-DAPT Study. The clinical...
Lack of Physician Guidance, Fear of Side Effects Influence Statin Compliance
News | Antiplatelet and Anticoagulation Therapies | April 15, 2019
Despite national guidelines indicating statins can lower risk of heart attack and stroke, many patients who could...
Overlay Init