Golden State Medical Supply has become the latest pharmaceutical company to recall ranitidine-containing heartburn drugs that might be contaminated with a cancer-causing chemical.
Ranitidine is the generic name for Zantac.
Various drug makers – including Sandoz, GlaxoSmithKline, and Sanofi-Aventis — have been recalling generic and name-grand versions of Zantac since September, after the U.S. Food & Drug Administration warned that the drugs might contain a probable human carcinogen called N-nitrosodimethylamine (NDMA).
The Golden State recall includes all lots and quantities of ranitidine 150mg and 300mg capsules manufactured by Novitium Pharma LLC with certain expiration dates listed in the company’s recall notice.
“Consumers taking Ranitidine HCl capsules are advised to consult with their physician, pharmacist, or healthcare provider about an alternative treatment prior to discontinuing the use of the medication,” the notice states. “Once an alternative treatment has been prescribed, the patients are instructed to contact Novitium‘s recall processor to obtain instructions and kit for returning the remaining product in their possession.”
Novitium‘s recall processor —Stericycle Return Management Services – can be reached by calling (866) 382-8606 or at Novitiumpharma6639@stericycle.com.
The FDA was informed of the contamination by Valisure, an online pharmacy that found NDMA in every batch of ranitidine and Zantac it tested, and frequently at levels far higher than the FDA’s daily limits.
Valisure has asserted that NDMA resulted from the ranitidine molecule’s instability, which purportedly degrades when subjected to conditions similar to human digestion. While the FDA indicated its early testing suggested this isn’t the case, the agency plans to conduct human tests to better understand whether ranitidine produces NDMA in the stomach after ingestion.
At least 10 Zantac or ranitidine recalls have been announced since the FDA issued its initial warning on September 13th. Several retailers, including CVS, Walmart, Walgreens, and Rite-Aid, have pulled the drugs from their stores, and regulators in more than 40 other countries have halted ranitidine sales or taken other steps to protect consumers.
The FDA hasn’t ordered a Zantac or ranitidine recall, and all such actions in the United States have been voluntary. The agency has, however, advised consumers taking over-the-counter ranitidine products to consider switching to an alternative heartburn medication. Those using prescription versions should not stop taking their medication without talking to their doctor, as doing so could worsen the condition being treated.