Sandoz Inc has voluntarily recalled all generic Zantac (ranitidine) in the United States because of "confirmed" contamination with the likely human carcinogen N-nitrosodimethylamine (NDMA) in some product batches, the company announced September 23.
The recall of Sandoz ranitidine hydrochloride capsules (150 mg and 300 mg) is to the consumer level and includes all quantities and lots of unexpired product.
The recall by Sandoz, the generics division of Novartis, follows the company's announcement last week that it was halting distribution of generic versions of the popular heartburn medicine after finding levels of NDMA that were higher than levels established by the US Food and Drug Administration (FDA), as reported by Medscape Medical News.
This recall is being conducted with the knowledge of the FDA, according to the company.
Sandoz said that to date, it has not received any reports of adverse events related to use of the recalled product.
Ranitidine is taken by millions worldwide for gastrointestinal disorders and discomfort. Sandoz/Novartis is one of several generic drugmakers that distribute it. French drugmaker Sanofi makes branded Zantac that is sold without a prescription. Ranitidine is sold in both over-the-counter and prescription versions.
Leslie Pott, Sandoz vice president for communications, told Medscape Medical News that the company was first alerted to the problem when the Swiss Health Authority, Swissmedic, reported finding traces of NDMA at levels higher than the levels established by health authorities in two batches of ranitidine film-coated tablets (Ranimed Sandoz 150 mg and Ranimed Sandoz 300 mg film-coated tablets).
"In response, we immediately placed a release and distribution stop on all Sandoz ranitidine-containing medicines in all our markets [announced on September 18] and started internal testing for NDMA," said Pott.
"These analyses are ongoing. However, after internal tests confirmed contamination with NDMA above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules, Sandoz immediately initiated a recall in the US," she explained.
Sandoz has notified its distributors and customers of this recall via overnight mail and via the Sandoz website and has arranged for the return of all recalled products. Wholesalers (direct customers) are being asked to immediately stop distribution, to return any stock to Sandoz, and to inform the retail pharmacies in their group to do the same. Pharmacies have been asked to immediately stop dispensing Sandoz ranitidine hydrochloride capsules.
More information, including lot numbers and national drug codes, is available online.
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Cite this: Sandoz Recalls Generic Zantac in US in Wake of Sales Halt - Medscape - Sep 24, 2019.