Drug major Sun Pharmaceutical Industries Inc. (the US subsidiary of Sun Pharma), initiated a nationwide recall of its Carvedilol Tablets used in the treatment of high blood pressure and heart failure. While Sun Pharma was the distributing firm, the tablets were manufactured at its subsidiary – ALKALOIDA Chemical Company located in Hungary.
Carvedilol is used after a heart attack to improve the chance of survival if your heart is not pumping well. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.
This drug works by blocking the action of certain natural substances in your body, such as epinephrine, on the heart and blood vessels. This effect lowers your heart rate, blood pressure, and strain on your heart. Carvedilol belongs to a class of drugs known as alpha and beta blockers.
An action basically taken to remove the particular product from the market can be done by either the company itself or by the FDA under its own statutory authority. In this case, it is a Voluntary recall initiated by the company itself.
The recall has been initiated in the US alone and has been classified as a Class III recall which means the exposure to this recalled product is not likely to cause adverse health consequences.
The batches recalled have an expiry date of February, 2017 with the recall initiation since June, 2016.
While not all details have been divulged by the company or the FDA, the simple reason stated is “Failed Dissolution Specifications” – Dissolution is principally useful as a QC test. Dissolution testing is required for all solid oral Pharmacopeial dosage forms in which absorption of the drug is necessary for the product to exert the desired therapeutic effect.
Whenever a dissolution test fails to meet specifications, an investigation should be performed to determine the cause(s) of the failure. In this case, no information is available if the company performed a dissolution test post receipt of complaints as this was a voluntary recall and not an FDA driven.
We will wait for the company to issue a press release so as to identify the financial impact of this recall.
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