- May 5, 2024
Cipla, Glenmark recall drugs from US market: USFDA – Times of India
NEW DELHI: Drug makers Cipla and Glenmark are recalling products from the American market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), a New Jersey-based subsidiary of Cipla is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution.
The medication, produced at the company’s Indore SEZ plant, is used to help control the symptoms of lung diseases, such as asthma, chronic bronchitis and emphysema.
Cipla USA is recalling the affected lot due to “short fill”. There were complaints of less fill volume in respule and few drops of liquid observed in the intact pouch, USFDA said.
Cipla initiated the Class II recall in the US market on March 26 this year.
USFDA also said that Glenmark Pharma 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.
As per USFDA, a class II recall is initiated in a situation in which the 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.
India is the largest supplier of generic medicines, with around 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.
The products manufactured in the country are shipped to over 200 countries around the globe, with Japan, Australia, Western Europe and the US as the main destinations.
India has the highest number of USFDA-compliant companies with plants outside the US.
The medication, produced at the company’s Indore SEZ plant, is used to help control the symptoms of lung diseases, such as asthma, chronic bronchitis and emphysema.
Cipla USA is recalling the affected lot due to “short fill”. There were complaints of less fill volume in respule and few drops of liquid observed in the intact pouch, USFDA said.
Cipla initiated the Class II recall in the US market on March 26 this year.
USFDA also said that Glenmark Pharma 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.
As per USFDA, a class II recall is initiated in a situation in which the 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.
India is the largest supplier of generic medicines, with around 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.
The products manufactured in the country are shipped to over 200 countries around the globe, with Japan, Australia, Western Europe and the US as the main destinations.
India has the highest number of USFDA-compliant companies with plants outside the US.
