Aurobindo recalls prescription and over-the-counter ranitidine
Posted: 14 November 2019 | Rachael Harper (European Pharmaceutical Review) | No comments yet
Aurobindo has recalled prescription and over-the-counter ranitidine due to the medications containing unacceptable levels of NDMA.
Aurobindo has recalled prescription and over-the-counter (OTC) ranitidine tablets (150mg), prescription ranitidine capsules (150mg and 300mg) and ranitidine syrup (15mg/mL) manufactured by Aurobindo Pharma USA, the US Food and Drug Administration (FDA) has announced.
This is due to the medications containing unacceptable levels of N-nitrosodimethylamine (NDMA).
The FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine).
Consumers may not know if the OTC ranitidine in their homes contains NDMA above the acceptable daily intake level because these recalls have been to the retail level, meaning they were only removed from store shelves. The NDMA levels the FDA found are similar to the levels a consumer would expect to be exposed to when eating common foods like grilled and smoked meats.
Consumers taking OTC ranitidine may consider using other OTC products approved for their condition, the FDA has said, stating that its tests of samples of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) show no NDMA in the medicines to date.
The FDA has advised that patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.
