Cipla and Glenmark issue recalls in the US drug market

Cipla and Glenmark issue recalls: Two prominent pharmaceutical companies, Cipla and Glenmark, have announced product recalls in the American market due to manufacturing concerns, according to reports from the US health regulatory body.

Cipla's New Jersey-based subsidiary is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulphate Inhalation Solution from its Indore SEZ plant, citing issues related to "short fill" in the medication's respules. This medication is crucial for managing lung diseases such as asthma, chronic bronchitis, and emphysema.

The recall, classified as Class II by the US Food and Drug Administration (USFDA), was initiated on March 26, 2024, following complaints regarding the fill volume and liquid observed in the packaging.

Similarly, Glenmark Pharmaceuticals Inc, USA, has recalled 3,264 bottles of Diltiazem Hydrochloride extended-release capsules due to "failed dissolution specifications." The nationwide recall was launched on April 17, 2024.

A Class II recall, as defined by the USFDA, denotes a situation where exposure to the product might cause temporary adverse health consequences or where the probability of serious health risks is remote.

India, known as a major supplier of generic medicines, contributes approximately 20% to the global supply, manufacturing over 60,000 different generic brands across 60 therapeutic categories. Its pharmaceutical products reach over 200 countries, with the US, Japan, Australia, and Western Europe being primary destinations.

India boasts the highest number of USFDA-compliant companies with manufacturing facilities outside the US, underscoring its significant role in the global pharmaceutical industry.

(with PTI inputs)