Several Indian pharmaceutical companies are recalling medicines from the US market due to various issues, including manufacturing problems, impurities, and labeling errors, as reported by the US Food and Drug Administration (USFDA). The recalls affect a range of products, including Azelaic Acid Gel, a combination drug for attention deficit hyperactivity disorder (ADHD), a renal imaging agent, Entecavir tablets, and other medicines.
Glenmark Pharmaceuticals is recalling 13,824 tubes of Azelaic Acid Gel due to complaints of a gritty texture, which may cause temporary or reversible health issues. Granules India is recalling over 49,000 bottles of a combination ADHD drug after it failed impurity and degradation tests. Sun Pharma’s US subsidiary is recalling 1,870 kits of a renal imaging agent following failed dissolution tests. Zydus Pharmaceuticals is recalling 8,784 bottles of Entecavir tablets due to impurity and degradation concerns. Unichem Pharmaceuticals has issued a Class I recall for 230 bottles of medicine because of a label mix-up, which could lead to significant health risks if patients take the wrong medicine.
The USFDA classifies recalls based on the level of risk associated with the product. Class I recalls are considered the most serious, as they could lead to significant health risks. Class II recalls are made when the use of a product may cause temporary or reversible health issues, but the risk of serious problems is low. Class III recalls are made when the product is unlikely to cause harm.
Despite these recalls, India has the highest number of USFDA-approved pharmaceutical plants outside the United States. The country’s pharmaceutical industry is a significant player in the global market, with many Indian companies exporting medicines to the US and other countries. The recalls highlight the importance of ensuring the quality and safety of pharmaceutical products, and the need for companies to adhere to strict manufacturing and testing standards.
The recalls are a result of the USFDA’s strict regulatory oversight, which aims to protect public health by ensuring that pharmaceutical products are safe and effective. The agency’s Enforcement Report provides information on recalls, warnings, and other regulatory actions taken against companies that fail to comply with USFDA regulations. The report helps to maintain transparency and accountability in the pharmaceutical industry, and ensures that companies take prompt action to address any issues related to their products.