New Delhi: According to the US health regulator, drugmakers Cipla and Glenmark are recalling their products from the US market due to manufacturing issues.
Cipla's New Jersey-based subsidiary is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, according to the latest enforcement report issued by the US Food and Drug Administration (USFDA).
The drug, produced at the company's Indore SEZ plant, is used to control symptoms of lung diseases such as asthma, chronic bronchitis and emphysema.
Cipla USA is recalling affected lots due to "short fill". The USFDA said there were complaints of low fill volume in the refills and a few drops of liquid were observed in the intact pouch.Cipla initiated a Class II recall in the US market on March 26 this year.
The USFDA also said Glenmark Pharma is recalling 3,264 bottles of diltiazem hydrochloride extended-release capsules indicated for high blood pressure.
The US-based branch of the company – Glenmark Pharmaceuticals Inc., USA – is withdrawing the drug due to “failed dissolution specifications”.
The company initiated a nationwide (US) recall on April 17, 2024.
According to the USFDA, a Class II recall is initiated in a situation where use of or exposure to a violative product is likely to cause temporary or medically significant adverse health consequences or where the likelihood of serious adverse health consequences is low.India is the largest supplier of generic drugs, manufacturing 60,000 different generic brands across 60 therapeutic categories and accounting for about 20 per cent of the global supply.
Products manufactured in the country are shipped to more than 200 countries around the world, with Japan, Australia, Western Europe and the US being the main destinations.
India has the highest number of USFDA-compliant companies with plants outside the US.
Cipla's New Jersey-based subsidiary is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, according to the latest enforcement report issued by the US Food and Drug Administration (USFDA).
The drug, produced at the company's Indore SEZ plant, is used to control symptoms of lung diseases such as asthma, chronic bronchitis and emphysema.
Cipla USA is recalling affected lots due to "short fill". The USFDA said there were complaints of low fill volume in the refills and a few drops of liquid were observed in the intact pouch.Cipla initiated a Class II recall in the US market on March 26 this year.
The USFDA also said Glenmark Pharma is recalling 3,264 bottles of diltiazem hydrochloride extended-release capsules indicated for high blood pressure.
The US-based branch of the company – Glenmark Pharmaceuticals Inc., USA – is withdrawing the drug due to “failed dissolution specifications”.
The company initiated a nationwide (US) recall on April 17, 2024.
According to the USFDA, a Class II recall is initiated in a situation where use of or exposure to a violative product is likely to cause temporary or medically significant adverse health consequences or where the likelihood of serious adverse health consequences is low.India is the largest supplier of generic drugs, manufacturing 60,000 different generic brands across 60 therapeutic categories and accounting for about 20 per cent of the global supply.
Products manufactured in the country are shipped to more than 200 countries around the world, with Japan, Australia, Western Europe and the US being the main destinations.
India has the highest number of USFDA-compliant companies with plants outside the US.
