Canada-based Apotex Inc is reported to be recalling a massive over 1.17 lakh bottles of Cevimeline Hydrochloride Capsules in the US that has been made by the company’s Indian arm Apotex Research Pvt Ltd. The reason for this development given is the “failed stability specifications of the 1,17,644 bottles of the drug under consideration, as confirmed on 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 Inc had recalled 91,962 bottles of Losartan potassium tablets in the US that were also made by Bangalore-based Apotex Research Pvt Ltd.