The fallout from the discovery of contamination in ranitidine medicine continues, with Sandoz extending its previously announced recall to ‘all quantities and lots’ of ranitidine hydrochloride capsules in the US.
The recall was made after contamination of its products was confirmed at levels deemed acceptable by the US Food and Drug Administration (FDA).
The company noted that it had not received any reports of adverse events by patients using the medication.
N-Nitrosodimethylamine (NDMA) is the contaminant found within ranitidine-based medicines across the industry. It is considered a probable carcinogen in humans.
The discovery of NDMA contamination of medicines was made by Valisure, an online pharmacy, which then submitted a Citizens Petition to the FDA, after finding the existence of NDMA “in every lot tested, across multiple manufacturers and dosage forms,” the pharmacy stated.
Ranitidine is an antacid medication that is used to treat peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome.
Sandoz sells ranitidine medicine in 150mg and 300mg doses, in various capsule quantities. The company has already notified distributors and customers of the recall.