You are here: Home » Companies » News
Business Standard

Apotex recalls India arm's medicine in US

Press Trust of India  |  New Delhi 

Canada-based Apotex is recalling 117,644 bottles of Cevimeline Hydrochloride Capsules in the US that were made by the firm’s Indian arm Apotex Research.

The company is recalling the drug due to “failed stability specifications”, as per the US Food and Drug Administration (USFDA) website.

Cevimeline Hydrochloride Capsules are used for treatment of symptoms of dry mouth in patients with Sjogren’s Syndrome.

The recall of the product in 30 mg strength in 100 and 500 count bottles, was initiated by the company on August 17.

It has been classified as a ‘Class-II recall’ which FDA defined as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”.

The company could not be immediately contacted for its comments. Sjogren's syndrome is a chronic autoimmune disease in which the body’s white blood cells destroy the exocrine glands, specifically the salivary and lacrimal glands, that produce saliva and tears respectively.

Earlier this year, Apotex had recalled 91,962 bottles of Losartan potassium tablets in the US made by Bengaluru-based Apotex Research.

Dear Reader,


Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor

First Published: Sun, September 27 2015. 23:24 IST
RECOMMENDED FOR YOU
.