Sandoz expands recall to include all lots of ranitidine

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Rich Townsend)
(Image: Getty/Rich Townsend)

Related tags: Sandoz, Ranitidine, NDMA, Recall

Sandoz has moved to recall all quantities and lots of ranitidine hydrochloride capsules from the US market due to contamination with NDMA.

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.

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