- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Apotex Inc recalls capsules made by its Indian arm
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.
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.
Next Story