Ranitidine Recalled Due to Carcinogen
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) expected compliance with its directive to remove all products from stores containing ranitidine. Ranitidine, also known by the brand name Zantac, contains a potential human carcinogen identified as N-Nitrosodimethylamine, or NDMA for short. Stores complied. Now, all ranitidine-based products have been removed from consumer outlets. However, the FDA, according to the Miami Herald, is demanding that a related drug called Nizatidine must be recalled as well because of the possibility that Nizatidine could contain NDMA as a by-product. Amneal Pharmaceuticals produces ulcer and heartburn medication with Nizatidine as its active ingredient. Amneal Pharmaceuticals agreed to recall its medication despite no reports of adverse events, illnesses, or deaths related to elevated NDMA quantities.
Amneal Pharmaceuticals, with the approval of the FDA, announced the recall initiative of its Nizatidine Oral Solution 15 mg/ml. The company identified the recalled lots as all having the NDC No. 60846-301-15. The company also said that lot number 06598004A has an expiration date of April of 2020. Also, lot number 06599001A is set to expire in December of 2020. Finally, lot 06599002A is scheduled to expire in December of 2020 as well.
Similar to ranitidine, Nizatidine users must cease the consumption of the drug immediately. The FDA, according to the Miami Herald, asked users to dispose of the drugs. Additionally, the FDA indicated that pharmacies have several alternative therapies to provide to patients who need heartburn, ulcer, and acid reflux relief. Alternative therapies to Nizatidine include over-the-counter medications such as Pepcid (famotidine), Prilosec (omeprazole), Prevacid (lansoprazole), Tagamet (cimetidine), and Nexium (esomeprazole).
Testing conducted by third-parties in 2019 indicated levels of NDMA increase with the passage of time while the medication is stored. The FDA regards NDMA as a probable carcinogen, and in 2019 began announcing several recall programs designed to remove all products that might contain NDMA.
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