Strides' ranitidine gets Oz nod
On 13 September, the US FDA had issued a safety alert citing traces of NDMA in ranitidine.
Chennai: As many as 20 batches of heartburn drug ranitidine manufactured by Strides Pharma for the Australian market have been found to have N-nitrosodimethylamine (NDMA) within permissible limits. These batches are now back on the retail shelves in that country. Meanwhile, Dr Reddy’s Laboratories have recalled all its ranitidine medications in the US.
Strides had suspended the manufacturing and sale of its ranitidine tablets for the US and Australian markets on September 27, 2019 due to the concerns about the presence of NDMA, which is associated with an increased risk of cancer. On 13 September, the US FDA had issued a safety alert citing traces of NDMA in ranitidine.
Dr Reddy’s meanwhile said it had initiated a voluntary nationwide recall on October 1 of all of its ranitidine medications sold in US due to confirmed contamination with NDMA above levels established by the FDA.