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Cipla, Glenmark recall products from US market due to manufacturing issues

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Cipla USA is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution  

Two Indian pharmaceutical companies, Cipla and Glenmark, are pulling back certain products from the American market due to manufacturing concerns, according to 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 due to “short fill”, news agency PTI reported, quoting the latest Enforcement Report issued by the US health regulator.

Produced at the company’s Indore SEZ plant, this medication is used to manage symptoms associated with lung diseases, such as asthma, chronic bronchitis and emphysema.

Cipla USA decided to recall the affected lot following complaints of less fill volume in respule and few drops of liquid observed in the intact pouch, the USFDA said, adding that the drug maker initiated the Class II recall in the US market on March 26 this year.

The regulator explained that a class II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible adverse health effects or when the likelihood of serious adverse health effects is low.

Meanwhile, the US-based arm of Glenmark Pharma is recalling 3,264 bottles of Diltiazem Hydrochloride extended-release capsules due to “failed dissolution specifications”.

USFDA report revealed that Glenmark Pharmaceuticals Inc, USA initiated the nationwide (US) recall of the medication, indicated for high blood pressure, on April 17, 2024.

India is known as the largest supplier of generic medicines, accounting for around 20 per cent of the global market share. It manufactures an extensive range of 60,000 different generic brands spanning across 60 therapeutic categories, which are shipped to over 200 countries around the globe, with Japan, Australia, Western Europe and the US being the main destinations.

Furthermore, India has the highest number of USFDA-compliant companies with plants outside the US, as reported by PTI.

 

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