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May 5, 2024

Cipla and Glenmark Recall Drugs in the US: USFDA Flags Manufacturing Issues

Cipla and Glenmark, two major pharmaceutical companies, have initiated recalls of their products in the United States due to manufacturing concerns, as reported by the US Food and Drug Administration (USFDA).

According to the latest Enforcement Report by the USFDA, a New Jersey-based subsidiary of Cipla is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution. This medication, manufactured at the company’s Indore SEZ plant, is utilized to manage symptoms of lung diseases such as asthma, chronic bronchitis, and emphysema.

The recall by Cipla USA is due to a “short fill” issue, with complaints of inadequate fill volume in respules and observations of liquid in the intact pouch, as noted by the USFDA. The Class II recall in the US market was initiated by Cipla on March 26, 2024.

Similarly, 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 nationwide recall in the US began on April 17, 2024.

USFDA classifies these recalls as Class II, indicating that the use of or exposure to the affected products may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

India holds the distinction of being the largest supplier of generic medicines globally, with approximately 20 percent share in the global supply, manufacturing 60,000 different generic brands across 60 therapeutic categories. These products are shipped to over 200 countries, with Japan, Australia, Western Europe, and the US being the primary destinations.

Furthermore, India boasts the highest number of USFDA-compliant companies with plants outside the US. This underscores the country’s commitment to maintaining high-quality manufacturing standards and ensuring the safety and efficacy of its pharmaceutical products on the global stage.

In light of these recalls, it becomes crucial for pharmaceutical companies to uphold rigorous quality control measures to prevent manufacturing issues that could jeopardize patient safety and trust in generic medications.

The actions taken by Cipla and Glenmark underscore the importance of regulatory oversight and adherence to quality standards in the pharmaceutical industry, particularly in the context of global supply chains.

Jhumpa Lahiri

Jhumpa Lahiri

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