Last Updated on December 16, 2024 by The Health Master
Drug recall
Several prominent Indian pharmaceutical companies, including Aurobindo Pharma, Glenmark, and Zydus, have initiated drug recall in the United States due to quality control issues.
These drug recall, categorized as Class II by the US Food and Drug Administration (USFDA), highlight the importance of stringent manufacturing standards in the global pharmaceutical industry.
Aurobindo Pharma Recalls Cinacalcet Tablets
Aurobindo Pharma USA Inc., a subsidiary of Hyderabad-based Aurobindo Pharma, is recalling over 100,000 bottles of Cinacalcet tablets in various strengths.
The drug recall is prompted by the detection of N-nitrosodimethylamine (NDMA), a potential carcinogen, above the USFDA’s acceptable limits.
Cinacalcet is primarily used to treat hyperparathyroidism, a condition affecting the parathyroid glands.
Must read: CDSCO Guidelines on Drug Recall
Glenmark Pharmaceuticals Recalls Diltiazem Hydrochloride Capsules
Glenmark Pharmaceuticals Inc., a US-based subsidiary of Glenmark Pharmaceuticals, is recalling approximately 90,000 bottles of Diltiazem Hydrochloride extended-release capsules.
The drug recall is triggered by the presence of N-nitroso-Desmethyl-Diltiazem impurity, which exceeds the USFDA’s interim limit.
Diltiazem is commonly prescribed to manage high blood pressure.
Zydus Pharmaceuticals Recalls Esomeprazole Magnesium Suspension
Zydus Pharmaceuticals (USA) Inc. is recalling 4,404 packs of Esomeprazole Magnesium for Delayed-Release Oral Suspension due to a labeling error.
Esomeprazole is a proton pump inhibitor used to treat acid reflux and other stomach-related conditions.
Understanding Class II Recalls
A Class II drug recall is issued when the use of a drug may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
India’s Role in Global Pharmaceutical Supply
India is a major global supplier of generic drugs, accounting for approximately 20% of the global market.
The country manufactures and exports a vast range of generic medications to over 200 countries, including the United States, Japan, Australia, and Western Europe.
Ensuring Quality and Safety
While these recent drug recalls underscore the need for robust quality control measures, it’s important to note that Indian pharmaceutical companies are committed to adhering to international standards.
The industry is taking proactive steps to address quality concerns and maintain its reputation as a reliable source of affordable, high-quality medications.
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What are the reasons for the drug recall?
The drug recall are due to the presence of impurities above acceptable limits and labeling errors.
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Which drugs are affected by the recalls?
The recalled drugs include Cinacalcet, Diltiazem Hydrochloride, and Esomeprazole Magnesium.
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What should consumers do if they have affected drugs?
Consumers should contact their healthcare provider or pharmacist for further guidance.
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Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.
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