US-based International Laboratories has issued voluntary nationwide recall of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level because of mislabeling.

The product is labeled as Clopidogrel tablets USP 75 mg but may feature Clopidogrel 75 mg or Simvastatin Tablets USP 10 mg.

The company noted that missed doses of Clopidogrel can increase a life threatening risk of heart attack and stroke. Patients should not stop taking clopidogrel without the prescription of a physician.

Besides, an unintentional consumption of simvastatin can lead to common side effects such as causing harm to fetus in pregnant woman. Simvastatin can also cause myopathy which is a disease of the muscles in some cases and finally, there is also a risk of allergic reactions which could also be life threatening.

The company reported that until now no complaints have been received related to this event with detailed medial illnesses or harmful effects.

Clopidogrel Tablets USP 75 mg are platelet inhibitor or blood thinner which are used for patients with acute coronary syndrome, recent MI, recent stroke, or established peripheral arterial disease. The tablets have been shown to reduce the rate of MI and stroke.

The company has given the differences between the Clopidogrel 75mg and Simvastatin 10 mg. While the former’s colour is light-pink to pink and is capsule shaped, the latter is light-pink and is round. The latter has ‘7153’ on one side, while the former has ‘7314’ on one side. The two tablets have ‘TV’ on their other sides.

The product has been distributed nationwide and delivered to distribution centers across Arkansas, Georgia, Indiana, California and Maryland and has been distributed to retail stores in all the US States.

International Laboratories is also notifying distributors and customers by letter and is arranging for return of all recalled products. The company has urged consumers who have bought the product to stop using it and return it to the location of purchase for a full refund.

The company has also advised consumers to contact their physician or healthcare provider if they are experiencing any health concerns which could be related to using this particular product.

International Laboratories also stated that consumers who are experiencing adverse reactions or quality problems associated with the use of the product may also report to FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 

The recall is being undertaken with the knowledge of the US Food and Drug Administration (FDA).


Image: International Laboratories recalls Clopidogrel tablets due to mislabeling. Photo: Courtesy of PR Newswire.