GSK joins other drugmakers recalling Zantac products 

Zantac
GlaxoSmithKline, the original developer of heartburn medicine Zantac, is recalling the ranitidine medicines globally. It doesn't sell them in the U.S., where Sanofi now owns the brand. (Sanofi)

GlaxoSmithKline has decided that stopping distribution of its Zantac products just won’t cut it. The U.K. company has decided it is time to pull the ranitidine heartburn meds off of retail shelves. 

The U.K.’s Medicines and Healthcare products Regulatory Agency Tuesday said GSK informed it that is recalling all unexpired Zantac prescription meds from pharmacies “due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.”

RELATED: FDA now says impurity level in Zantac and other antacids is too high

On-Demand Webinar

De-Risking the Solid Form Landscape of an API

This presentation will discuss how predictable stability and solubility can minimize development timelines and cost. Attend to hear about two case studies exemplifying the importance of understanding the hydration space of an API and how hydrate formation may be avoided by development of a robust crystallization procedure.

GSK, the original developer of the antacid Zantac, in an emailed comment today pointed out that it does not sell Zantac prescription or over-the-counter products in the U.S. Sanofi has U.S. rights to the brand. In the U.K., and elsewhere, though, GSK is retrieving the meds. 

“As a precautionary measure, GSK has made the decision to initiate a voluntary recall (pharmacy/retail level recall) of Zantac products in all markets. Patient safety remains our utmost priority and we are taking this issue very seriously,” the company said. 

GlaxoSmithKline initially stopped distribution of the drugs after the FDA notified the public that it had learned NDMA was formed during the manufacturing of Zantac and its ranitidine generics. At the time, the agency said the amounts and attendant risks seemed small but that it was still investigating. NDMA is one of the potential carcinogens the FDA last year learned could also be formed during the manufacturing of certain sartan high blood pressure meds that led to a global recall.

RELATED: FDA needs to recall Zantac and other ranitidine antacids, says pharmacy that uncovered impurity

Some drugmakers, like Novartis’ Sandoz, Apotex and Dr. Reddy’s Laboratories, went ahead and recalled their Zantac generics when the alert was first raised by the FDA. Pharmacy chains CVS, Walgreens, Rite Aid and Walmart, some of which have been sued for sales of contaminated blood pressure meds, also decided to strip their shelves of the over-the-counter antacids. The FDA has since reported that further tests found unacceptably high levels of the impurity in the drug prompting more drugmakers to initiate voluntary recalls.

The very first pharmacy to act was Valisure, an online retailer whose testing had determined that NDMA was present in ranitidine drugs. Valisure then filed a Citizen Petition with the FDA seeking to have the agency pull ranitidine drugs from the market and create viable tests for NDMA in them.

The FDA does not agree with using Valisure's “high temperature” testing but has developed its own method for drugmakers to test their own products.

Suggested Articles

J&J's talc woes deepened Friday after the FDA turned up "sub-trace" levels of asbestos one bottle of the company's baby powder,…

Another major drugmaker is recalling in the U.K. 10 batches of its Zantac generics because they contain a possible carcinogen.

With diagnosis rates on the rise, Pfizer's Vyndaqel franchise could collect $157 million in 2019 U.S. sales, well above consensus, SVB Leerink says.