FDA tarafından yapılan açıklamada içinde kanserojen gayrisafi madde olduğu gerekçesi ile ABD de SANDO'a ait 150 ve 300 mg ranitidin preparatlarını yasakladı ve eczacılara bu ilacı hastalara vermeyin uyarısı yaptı.
TOPIC: Ranitidine Hydrochloride Capsules, 150mg and 300mg by Sandoz: Recall - Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
ISSUE: Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules in the United States to the consumer level because of confirmed contamination with NDMA above levels established by the FDA in batches of Sandoz's Ranitidine Hydrochloride Capsules. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
To date, Sandoz has not received any reports of adverse events related to use of the product as part of this recall. The product can be identified by the NDC number and lot number provided in the recall. Click the read recall button below to find product specific information.
RECOMMENDATION: Pharmacies should immediately stop dispensing Sandoz's Ranitidine Hydrochloride Capsules and return remaining stock to Sandoz. Consumers should continue taking their medication and speak to their physician or pharmacist about alternative treatment options.
Health care professionals, patients and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: