- 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
Lupin arm recalls high BP drug Quinapril in US over presence of nitrosamine impurity
The company advised patients taking the Quinapril tablets "to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment".
New Delhi: Pharmaceuticals firm Lupin Ltd on Thursday said its US-based arm is recalling four lots of Quinapril tablets used to treat high blood pressure due to the presence of a nitrosamine impurity.
Lupin Pharmaceuticals Inc, the company's wholly-owned arm, is recalling the said tablets due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the acceptable daily intake (ADI) level, Lupin Ltd said in a regulatory filing.
"To date, Lupin has received no reports of illness that appear to relate to this issue," it said, adding it discontinued marketing of Quinapril tablets in September 2022.
Quinapril tablets of strengths 20mg and 40mg packaged in separate 90-count bottles were distributed nationwide in the US to wholesalers, drug chains, mail-order pharmacies, and supermarkets, it added.
The filing further said Lupin Pharmaceuticals Inc is notifying its wholesalers, distributors, drug chains, mail-order pharmacies, and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots while asking them to discontinue distribution of the recalled lots immediately.
Read also: Lupin arm acquires right to Limbitrol, Bacrocin and 7 other medicines from Bausch Health
The company, however, advised patients taking the Quinapril tablets "to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment".
"This recall is being conducted with the knowledge of the US Food and Drug Administration," it added.
Read also: Sun Pharma, Dr Reddy's Labs recall products in US over manufacturing issues
The company said nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables.
While everyone is exposed to some level of nitrosamines, these impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time, it added.
Read also: Lupin, Zydus Lifesciences recall products in US over manufacturing issues
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751