Aifa recalls some batches of Buscopan, Zantac, Ranidil from the market: 'potentially carcinogenic'

The list of batches of drugs for the treatment of gastric problems containing the active ingredient ranitidine, recalled from the market due to the presence of an impurity considered potentially carcinogenic, is growing. The latest list published by the Italian Medicines Agency (AIFA) lists over 500 batches, including 13 batches of Buscopan. On September 20, an initial list of batches of drugs containing the active ingredient ranitidine, manufactured by SARACA LABORATORIES LTD in India, recalled due to their presence in N-nitrosodimethylamine (NDMA) was released. With the new update, the number of batches recalled as a precaution, pending investigation, has increased from 195 to over 515. These batches include 13 batches of Buscopan 75 mg effervescent tablets, expiring on May 1, 2021. The long list also includes 34 batches of Zantac, including tablets, vials, and syrup. And, among others, 22 batches of Ranibloc, several batches of Raniben, Ranidil, Ulcex, Ranitidine Zentiva, and Ranitidine Hexa. The complete list is on the AIFA website. Ranitidine (a histamine H2 receptor antagonist), AIFA notes on its website, "is an acid secretion inhibitor used in the treatment of ulcers, gastroesophageal reflux disease, heartburn, and other conditions associated with acid hypersecretion." Other medications with the same therapeutic indications are available, "therefore, patients taking ranitidine-based medications should consult their doctor to discuss the possibility of alternative therapy." Measures similar to the recalls underway in Italy have been taken in other European and non-European countries, AIFA reports. The agency is working with the European Medicines Agency (EMA) and other European agencies "to assess the level of contamination in the affected products and adopt corrective measures."