USFDA has announced that Pharma company Dr. Reddy’s Labs and its subsidiaries have issued a nationwide recall voluntarily on its range of ranitidine medicines that are used to treat heartburn. Tests showed that some of the medicines were contaminated with N-Nitrosodimethylamine or NDMA. The component NDMA is a contaminant of impurity that is considered carcinogenic by US Environmental Protection Agency (USEPA). It can sometimes accidentally get introduced into manufacturing processes through certain chemical reactions.
The FDA has been testing several drugs when it found that there are impurities in heart failure and blood pressure management drugs called ARB’s.Till now Dr. Reddy’s Labs has not received any reports of illness related to patients taking the drug. Pharma retail stores like Walgreens, CVS Pharmacy and even Walmart announced that they will stop sales of ranitidine medications due to concerns that they may contain impurities.
During September this year Novartis stated that it will stop distribution of all ranitidine medication that is manufactured by Sandoz. Patients that are using medication made by Dr. Reddy’s stated that they should ask doctors and pharmacists about alternative treatment hereon. FDA is trying to determine the reason that is causing this contamination problem and is working with regulators to determine how the impurity is coming into these drugs.
NMDA is a contaminant that is found in water and food like meat, vegetables and dairy products. Ranitidine is an over the counter drug that is also given in prescriptions to relieving heartburn associated with acidic stomach issues of indigestion that is brought on when an individual eats or drinks certain beverages and foods. Rantidine is prescribed for short term treatment of problems like duodenal ulcer and as therapy medicine for patients at a reduced dosage for healing acute ulcer conditions and also for treatment of GERD. The products of Dr. Reddy’s Ranitidine pills can be identified by NDC numbers and all these generic medicines with expiry date of September 2019 and June 2021 are being.