CVS, Walgreens and Rite Aid pull Zantac and generics as recall spreads around the globe 

cvs
CVS is stripping its shelves of Zantac and its generics after the FDA said it has learned that manufacturing of ranitidine drugs has left the impurity NDMA in them. (CVS)

The Zantac recall is quickly turning into a landslide as national pharmacy chains pulled Zantac and its generics from its shelves and countries from Korea to Bangladesh asked makers to remove ranitidine drugs from their markets.

CVS Sunday said it was suspending sales of all Zantac brand and CVS Health brand ranitidine products until further notice. That came despite the fact the FDA has yet to seek the recall of the products or recommend that patients quit taking the heartburn med after it warned a suspected carcinogen has been found in them. 

“This action is being taken out of an abundance of caution due to a recent Product Alert from the U.S. Food and Drug Administration (FDA) that ranitidine products may contain a low level of nitrosodimethylamine (NDMA), which is a probable human carcinogen,” the national pharmacy retailer said in a statement

Sponsored by Lubrizol Life Science

[Webinar] Cannabinoid Formulation - from Farm to Pharma

Wednesday, June 24, 2020 | 12pm ET / 9am PT

A handful of cannabinoid-based pharmaceutical products are on the market today, and an ever-growing number are in the global development pipeline. This webinar will explore key considerations in developing cannabinoid-based pharmaceutical products, including an overview of global pharmaceutical cannabinoid usage today, common challenges formulating with CBD and other cannabinoids, and more.

It was followed on Monday by Walgreens and Rite Aid, The New York Times reported.

RELATED: Global threat gains steam as GlaxoSmithKline halts generic Zantac supply

The action followed recalls by some drugmakers in the U.S. and moves by regulators outside of the U.S. to restrict distribution or to have markets cleared of the drugs. GlaxoSmithKline, the original developer of Zantac, as well as Sandoz, Dr. Reddy’s Laboratories and Apotex all said they were recalling their ranitidine drugs from the U.S. market. 

Sanofi, which now owns the Zantac brand, has so far not taken that step. 

Regulators suspended sales of the drugs in South Korea, where the industry was interpreting a remark from an official with the Ministry of Food and Drug Safety that the drugs might now be allowed to return to the market, the Korea Biomedical Review reported. A temporary ban in Bangladesh was more targeted, applying only to drugs made with APIs from India’s Saraca Laboratories and Dr Reddy's, which have found elevated levels of NDMA in their ingredients. Those moves followed Canada’s step of asking drugmakers to halt sales of the drugs there. 

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

FDA alerted the public Sept. 13 that it had been determined that NDMA could be produced during the manufacturing of ranitidine drugs. At the time, it said the amounts found in the drugs appeared to be less than would be found in common foods, and their risks seemed small. 

The FDA was alerted to the existence of the impurity in ranitidine drugs by online pharmacy Valisure, which has filed a citizen petition to force the FDA to recall the drugs and create acceptable standards and tests for NDMA for drugmakers before they are returned to the market. 

Suggested Articles

The antidepressant Zoloft and its generics are in short supply as the COVID-19 pandemic has caused higher demand and manufacturing interruptions.

WuXi AppTec has appointed Celgene CAR-T program veteran David Chang to lead its cell and gene therapy CDMO, WuXi Advanced Therapies.

Merck CEO Ken Frazier has spoken passionately about racism before. Monday, amid protests over George Floyd's death, he made that passion personal.