Dr. Reddy’s and Zydus Lifesciences, two major Indian pharmaceutical companies, have initiated recalls of certain medicines in the US due to quality issues. The recalls were voluntarily undertaken by the companies by the US Food and Drug Administration (US FDA).
Dr. Reddy’s is recalling several lots of its Metformin Hydrochloride Extended-Release Tablets, which are used to treat type 2 diabetes, due to the detection of N-Nitrosodimethylamine (NDMA) impurities above the acceptable daily intake limit. NDMA is a known carcinogen and its presence in medications has been a major concern in recent years.
Zydus Lifesciences, on the other hand, is recalling certain lots of its Lisinopril Tablets, which are used to treat high blood pressure and heart failure. The recall was initiated due to the presence of an impurity called N-Methylnivaldipine, which is a known byproduct of the manufacturing process.
Both recalls are classified as Class II recalls, which means that the use of the affected products may cause temporary or medically reversible adverse health consequences. However, the FDA has stated that there is no immediate risk to patients who have taken the affected medications, and patients are advised to continue taking their medications as directed until they can obtain a replacement or alternative treatment.
The recalls are a result of the US FDA’s ongoing efforts to ensure the quality and safety of medications marketed in the US. The agency has been working closely with pharmaceutical companies to identify and address quality issues, including the presence of impurities in medications.
Dr. Reddy’s and Zydus Lifesciences have stated that they are committed to ensuring the quality and safety of their products and are cooperating fully with the US FDA to resolve the issues. The companies have also notified their distributors and retailers to stop further distribution of the affected products and to return any unused products to the company.
The recalls highlight the importance of quality control and monitoring in the pharmaceutical industry. Patients who have been taking the affected medications are advised to contact their healthcare provider or pharmacist for guidance on what to do next. The US FDA will continue to monitor the situation and take any necessary actions to ensure the safety and quality of medications marketed in the US.