Sanofi and Dr Reddy’s join the ranitidine recall

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/Michail Petrov 96)
(Image: Getty/Michail Petrov 96)

Related tags Ranitidine Sanofi Dr Reddy's US FDA Zantac Recall

Both companies issue a voluntary recall of their ranitidine-based products due to the ongoing investigation into cancer-causing contamination.

The discovery that certain ranitidine medicines contained N-nitrosodimethylamine (NDMA), a probable carcinogen, was made by online pharmacy Valisure and disclosed to the US Food and Drug Administration (FDA) by a Citizen Petition​, last month.

Following this, various companies​ have issued voluntary recalls, national regulators​ have recommended withdrawal of certain products from the market, and lawsuits have begun on behalf of consumers.

The treatment itself is commonly used for gastrointestinal conditions, such as heartburn, indigestion, and gastric ulcers.

Sanofi begins voluntary recall

The latest two companies to voluntarily recall their products from the market are Dr Reddy’s and Sanofi.

The latter company has recalled its branded Zantac over-the-counter (OTC) product, which is the most identifiable ranitidine-based product, after having arrived on the market in 1981 and establishing itself as one of the best-selling drugs of all time​, with $97.4bn (€87.5bn) in lifetime sales, according to EvaluatePharma.

Sales have since slowed down, with it now being off-patent, but the drug brought in approximately $128m during 2018 for Sanofi.

Sanofi explained that it had voluntarily withdrawn the product from the US and Canada as a ‘precautionary measure’ due to the potential for contamination with NDMA.

Outside of these countries, Sanofi will continue to sell the treatment, as it specified​ that the active pharmaceutical ingredients (APIs) are sourced from different suppliers to the product delivered to the US and Canadian markets.

A spokesperson for Sanofi was not immediately available for comment.

Dr Reddy’s joins move to issue recalls

Dr Reddy’s announced yesterday​ that it had initiated a voluntary nationwide recall in the US on October 1, at the retail level for OTC products and at the consumer level for prescription products.

The action was taken after the company confirmed that the FDA had discovered contamination of its ranitidine products, with NDMA levels above what is deemed acceptable by the agency.

Dr Reddy’s recall involves all of its ranitidine medicines sold in the US.

Related news

Show more

Related products

show more

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Manufacturing Drugs with Highly Potent APIs

Manufacturing Drugs with Highly Potent APIs

Content provided by Altasciences | 28-Sep-2023 | White Paper

In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...