Drug Makers Recall Products in the US: Aurobindo Pharma, Glenmark, and Zydus Face Issues

Indian pharmaceutical companies have once again come under scrutiny in the US market, with Aurobindo Pharma, Glenmark, and Zydus Pharmaceuticals initiating product recalls. The recalls, classified under Class II by the US Food and Drug Administration (USFDA), cite manufacturing and quality control issues. This article delves into the specifics of the recalls, their implications, and India’s pivotal role in the global pharmaceutical supply chain.

Aurobindo Pharma Recalls Cinacalcet Tablets

Aurobindo Pharma USA Inc, a subsidiary of Hyderabad-based Aurobindo Pharma, is recalling over 1 lakh bottles of Cinacalcet tablets in multiple strengths. The recall stems from GMP deviations identified as the presence of N-nitroso Cinacalcet impurity above the FDA’s recommended interim limit.

• Purpose of Cinacalcet: Used to treat hyperparathyroidism.
• Recall Initiation: November 7, 2024.
• Classification: Class II recall.

The presence of impurities exceeding FDA guidelines highlights the growing challenges faced by drug manufacturers in adhering to stringent global standards.

Glenmark Pharmaceuticals Recalls Diltiazem Hydrochloride Capsules

New Jersey-based Glenmark Pharmaceuticals Inc is recalling around 90,000 bottles of Diltiazem Hydrochloride extended-release capsules. The affected batches are linked to cGMP deviations, specifically the presence of N-nitroso-Desmethyl-Diltiazem impurity exceeding FDA’s interim limits.

• Purpose of Diltiazem Hydrochloride Capsules: Treat high blood pressure.
• Recall Initiation: November 1, 2024.
• Classification: Class II recall.

The company’s prompt action underlines the seriousness of addressing such quality deviations, especially for products treating critical conditions like hypertension.

Zydus Pharmaceuticals Recalls Esomeprazole Magnesium Packs

Zydus Pharmaceuticals (USA) Inc has recalled 4,404 packs of Esomeprazole Magnesium for Delayed-Release Oral Suspension (40 mg) due to a labelling error.

• Purpose of Esomeprazole Magnesium: Treats stomach and esophagus issues like acid reflux.
• Recall Initiation: November 14, 2024.
• Classification: Class II recall.

Though seemingly minor, labelling errors can lead to incorrect usage, potentially endangering patient safety.

Understanding Class II Recalls

A Class II recall indicates a product issue that may lead to temporary or medically reversible adverse health effects, with a low probability of serious consequences. These recalls underline the critical need for compliance with Good Manufacturing Practices (GMP) to ensure safety and efficacy.

India’s Role in the Global Pharmaceutical Industry

India plays a significant role in the global pharmaceutical market, producing 20% of the world’s generic medicines across 60 therapeutic categories. With exports reaching over 200 countries, including key markets like the US, Japan, and Europe, Indian companies are vital to the healthcare ecosystem.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.