Cipla and Glenmark, are recalling their products from the American market
Two pharmaceutical companies, Cipla and Glenmark, are recalling their products from the American market due to manufacturing issues. This was reported by the US health regulator. According to…
Two pharmaceutical companies, Cipla and Glenmark, are recalling their products from the American market due to manufacturing issues.
This was reported by the US health regulator.
According to the latest Enforcement Report released by the US Food and Drug Administration (USFDA), a subsidiary of Cipla based in New Jersey is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution.
This medication, manufactured at the company’s Indore SEZ plant, is used to control the symptoms of lung diseases like asthma, chronic bronchitis, and emphysema.
Cipla USA is recalling the affected lot due to “short fill” and complaints of less fill volume in respule, and a few drops of liquid observed in the intact pouch.
Glenmark Pharma, on the other hand, is recalling 3,264 bottles of Diltiazem Hydrochloride extended-release capsules indicated for high blood pressure. The US-based arm of the company,
Glenmark Pharmaceuticals Inc, USA, is recalling the medication due to “failed dissolution specifications”.
The company initiated the nationwide (US) recall on April 17, 2024.
According to the USFDA, Cipla initiated the Class II recall in the US market on March 26, 2024. A Class II recall is initiated when the use of a product that violates regulations may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
India is the world’s largest supplier of generic medicines, with around 20 per cent share in the global supply, manufacturing 60,000 different generic brands across 60 therapeutic categories.
India exports these products to over 200 countries around the globe, with Japan, Australia, Western Europe, and the US as the main destinations. India also has the highest number of USFDA-compliant companies with plants outside the US.