Zantac Generic Pulled From Markets Worldwide

Novartis unit says it’s stopping distribution while contamination is investigated

https://www.medpagetoday.com/gastroenterology/gerd/82238

One manufacturer of generic ranitidine (Zantac), Novartis’s Sandoz unit, has reportedly decided to halt distribution of the antacid drug until a contamination issue is resolved.

Last week, the FDA said some lots of ranitidine, a histamine H2 inhibitor, were found to contain small amounts of N-nitrosodimethylamine (NDMA), considered to be a human carcinogen. NDMA is a member of the nitrosamine family of chemicals also found to have contaminated some angiotensin receptor blocker drugs, sparking an uproar that still hasn’t died down.

“A precautionary distribution stop of all Sandoz ranitidine-containing medicines in all our markets will remain in place under further clarification, this includes capsules in the USA,” according to a Novartis statement quoted in the Wall Street Journal. “Our internal investigation is ongoing to determine further details. In case of concerns, adequate additional measures will be implemented in alignment with relevant Health Authorities as required.”

Ranitidine is sold in both prescription and over-the-counter (OTC) forms primarily to relieve gastroesophageal reflux and for gastric and intestinal ulcer prevention. The FDA didn’t indicate which particular products were affected since they are not being recalled at this time; the generic drug is available from other companies besides Sandoz.

Although no recall was ordered, the FDA said last week that patients using OTC ranitidine “could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”

Patients taking prescription ranitidine who wish to switch to another medication should consult their physicians, the FDA said.

Filed under: General Problems