Several Indian pharmaceutical companies are recalling medicines from the US market due to various issues, as reported by the US Food and Drug Administration (USFDA). The recalls are related to manufacturing problems, impurities, and labeling errors. Glenmark Pharmaceuticals is recalling 13,824 tubes of Azelaic Acid Gel due to complaints of a gritty texture. The recall, initiated on September 17, is classified as Class II, meaning the product may cause temporary or reversible health issues, but the risk of serious problems is low.
Other companies, such as Granules India, are also recalling products. Granules India is recalling over 49,000 bottles of a combination drug used to treat attention deficit hyperactivity disorder (ADHD) due to failed impurity and degradation tests. This recall is classified as Class III, indicating the product is unlikely to cause harm. Sun Pharma’s US subsidiary has recalled 1,870 kits of a renal imaging agent following failed dissolution tests, which is a Class II recall.
Zydus Pharmaceuticals is recalling 8,784 bottles of antiviral drug Entecavir tablets due to impurity and degradation concerns, also a Class II recall. Unichem Pharmaceuticals USA Inc has issued a Class I recall, the most serious type, for 230 bottles of medicine due to a label mix-up. This type of recall could lead to significant health risks if patients take the wrong medicine.
Despite these recalls, India has the highest number of USFDA-approved pharmaceutical plants outside the United States. The USFDA’s Enforcement Report highlights the need for strict quality control measures in the pharmaceutical industry. The recalls demonstrate the regulator’s efforts to ensure the safety and efficacy of drugs in the US market. The companies involved have initiated the recalls to protect public health and prevent potential harm to patients. The Class II and Class III recalls indicate that the risks associated with the products are relatively low, but the companies are taking proactive steps to address the issues and prevent future problems.