The FDA encourages patients and health care professionals to report any adverse reaction to the agency’s The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Patients taking prescription ranitidine or nizatidine who wish to stop use should talk to their health care professional about other treatment options. Ranitidine recall 2020: FDA asks for immediate withdrawal of all ranitidine drugs (such as Zantac) Updated Apr 01, 2020; Posted Apr 01, 2020 By The Oregonian/OregonLive November 15, 2019 --Golden State Medical Supply, Incorporated (GSMS, Inc) based upon a manufacturer’s recall by Novitium Pharma LLC (Novitium), is voluntarily instituting a recall of all quantities and lots, within expiry, of Ranitidine HCl 150mg and 300mg Capsules to the consumer level because of potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA. Drug recalls are actions taken by a firm to remove a product from the market and may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. To date, the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.FDA is continuing to test ranitidine products from multiple manufacturers and assess the possible effect on patients who have been taking ranitidine. The higher temperatures generated very high levels of NDMA from ranitidine products because of the test procedure.
Ranitidine Oral Solution, USP 150 mg/10 mL, is being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. Genotoxic substances such as NDMA may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains NDMA at-or-below the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer.There are multiple drugs that are approved for the same or similar uses as ranitidine and nizatidine. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. The NDMA levels FDA found are similar to the levels a consumer would expect to be exposed to when eating common foods like grilled and smoked meats.Consumers taking OTC ranitidine may consider using other OTC products approved for their condition. Zantac and store brand ranitidine is being recalled due to impurities found in certain samples.
FDA is alerting of a voluntary recall of prescription ranitidine distributed by Sandoz Inc.
To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the The FDA continues its ongoing review, surveillance, compliance and pharmaceutical quality efforts across every product area, and will continue to work with drug manufacturers to ensure safe, effective and high-quality drugs for the American public.The FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease. To date, FDA’s testing has not found NDMA in Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), or Prilosec (omeprazole).FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine). The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc. To see if the Zantac or ranitidine you have been using is part of the recall, please see our ranitidine recall list below.
FDA does not endorse either the product or the company.Precision Dose Inc. is voluntarily recalling 5 lots of Ranitidine Oral Solution, USP 150 mg/10 mL to the consumer level.
That method is not suitable for testing ranitidine because heating the sample generates NDMA.FDA will test ranitidine oral solution products and has begun testing samples of other H2 blockers and proton-pump inhibitors to help inform this ongoing investigation.
April 1, 2020. The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.