How ranitidine became a probable cancer risk: A timeline

Since the FDA first warned that ranitidine products may contain a potentially cancer-causing impurity, known as N-nitrosodimethylamine, numerous drugmakers have recalled their ranitidine products and some consumers have sued. 

Below is a timeline of ranitidine recalls, lawsuits and other announcements reported by Becker's Hospital Review

Sept. 13: The FDA warns patients and healthcare providers that some ranitidine medicines contain a potentially cancer-causing impurity called N-nitrosodimethylamine.

Sept. 19: Sandoz, the generic arm of Novartis, stops global distribution of its ranitidine drugs and recalled them in Canada and some European countries.

Sept. 23: Dr. Reddy's Laboratories stops worldwide shipments of ranitidine. The Italian Drug Agency and Germany's drug regulator both order recalls of all versions of Zantac, the brand-name version of ranitidine, with an active ingredient made in India's Saraca Laboratories.

Sept. 24: Sandoz expands its recall of ranitidine products to the U.S. 

Sept. 26: Apotex, a drugmaker headquartered in Canada, recalls all of its ranitidine products from the U.S. 

Sept. 26: GlaxoSmithKline, the original branded maker of Zantac, halts global distribution of Zantac. It also recalls the drug in India and Hong Kong.

Sept. 30: CVS Pharmacy suspends sales of Zantac and other ranitidine products at its drugstores.

Sept. 30: Walgreens and Rite Aid follow CVS Pharmacy in halting Zantac sales.

Oct. 2: Walmart joins CVS, Walgreens and Rite Aid in temporarily halting sales of Zantac and other ranitidine products.

Oct. 3: The FDA says an outside lab that reported very high levels of a carcinogen in ranitidine products used an "unsuitable" testing method, causing misleading results. However, the agency still calls the level of NDMA in the drug "unacceptable."

Oct. 9: GlaxoSmithKline recalls prescription-only versions of Zantac globally. 

Oct. 18: Sanofi recalls Zantac in the U.S., about a month after the first FDA warning.

Oct. 22: Three separate lawsuits are filed against GlaxoSmithKline, Pfizer, Boehringer Ingelheim and Sanofi for allegedly failing to disclose that ranitidine products can produce small amounts of a possible carcinogen.

Nov. 4: After months of testing, the FDA says the level of NDMA in ranitidine products was no higher than what is found in common foods like grilled or smoked meats.

Nov. 8: Aurobindo Pharma joins a growing list of drugmakers recalling their ranitidine products over concerns that they produce NDMA.

Nov. 12: American Health Packaging recalls eight lots of its 150 mg ranitidine syrup. 

Nov. 14:  Amneal Pharmaceuticals recalls more than 90 lots of its 150 mg and 300 mg ranitidine tablets and15 mg ranitidine syrup.

Nov. 19: Golden State Medical Supply recalls 19 lots of ranitidine capsules following a manufacturer's recall by Novitium Pharma.

Nov. 21: Precision Dose recalls five lots of its ranitidine oral solution in response to Amneal's recall, which included lots repackaged by Precision Dose. 

More articles on pharmacy:
AHA, CVS Health backed secretive anti-pharma group
EpiPen, Humira among drugs Warren wants to regulate
31 drugmakers at high risk for bankruptcy in 2020

Since the FDA first warned that ranitidine products may contain a potentially cancer-causing impurity, known as N-nitrosodimethylamine, numerous drugmakers have recalled their ranitidine products and some consumers have sued.

Below is a timeline of ranitidine recalls, lawsuits and other announcements reported by Becker's Hospital Review:

Sept. 13: The FDA warns patients and healthcare providers that some ranitidine medicines contain a potentially cancer-causing impurity called N-nitrosodimethylamine.

Sept. 19: Sandoz, the generic arm of Novartis, stops global distribution of its ranitidine drugs and recalled them in Canada and some European countries.

Sept. 23: Dr. Reddy's Laboratories stops worldwide shipments of ranitidine. The Italian Drug Agency and Germany's drug regulator both order recalls of all versions of Zantac, the brand-name version of ranitidine, with an active ingredient made in India's Saraca Laboratories.

Sept. 24: Sandoz expands its recall of ranitidine products to the U.S.

Sept. 26: Apotex, a drugmaker headquartered in Canada, recalls all of its ranitidine products from the U.S.

Sept. 26: GlaxoSmithKline, the original branded maker of Zantac, halts global distribution of Zantac. It also recalls the drug in India and Hong Kong.

Sept. 30: CVS Pharmacy suspends sales of Zantac and other ranitidine products at its drugstores.

Sept. 30: Walgreens and Rite Aid follow CVS Pharmacy in halting Zantac sales.

Oct. 2: Walmart joins CVS, Walgreens and Rite Aid in temporarily halting sales of Zantac and other ranitidine products.

Oct. 3: The FDA says an outside lab that reported very high levels of a carcinogen in ranitidine products used an "unsuitable" testing method, causing misleading results. However, the agency still calls the level of NDMA in the drug "unacceptable."

Oct. 9: GlaxoSmithKline recalls prescription-only versions of Zantac globally.

Oct. 18: Sanofi recalls Zantac in the U.S., about a month after the first FDA warning.

Oct. 22: Three separate lawsuits are filed against GlaxoSmithKline, Pfizer, Boehringer Ingelheim and Sanofi for allegedly failing to disclose that ranitidine products can produce small amounts of a possible carcinogen.

Nov. 4: After months of testing, the FDA says the level of NDMA in ranitidine products was no higher than what is found in common foods like grilled or smoked meats.

Nov. 8: Aurobindo Pharma joins a growing list of drugmakers recalling their ranitidine products over concerns that they produce NDMA.

Nov. 12: American Health Packaging recalls eight lots of its 150 mg ranitidine syrup.

Nov. 14: Amneal Pharmaceuticals recalls more than 90 lots of its 150 mg and 300 mg ranitidine tablets and15 mg ranitidine syrup.

Nov. 19: Golden State Medical Supply recalls19 lots of ranitidine capsules following a manufacturer's recall by Novitium Pharma.

Nov. 21: Precision Dose recalls five lots of its ranitidine oral solution in response to Amneal's recall, which included lots repackaged by Precision Dose.

© Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

 

Featured Webinars

Featured Whitepapers