Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
The Reason for Recalls
As described in the FDA article, "Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac)", the FDA is advising recalls of ranitidine if NDMA (N-nitrosodimethylamine) levels show above 96 ng or 0.32 parts per million, also known as the acceptable daily intake. Companies are recalling a ton of ranitidine products, whether test results show high NDMA levels or there are no test results- just the potential for risk is enough for some. Recalls have only applied to store shelves, so if you already have the medicine at home you may not know about the levels of NDMA in that product.
Companies choosing to recall the product just due to risk potential also means that there are stores and pharmacies doing the equivalent by not selling it for the same reason. The article notes, “Some pharmacies decided to remove ranitidine from their shelves out of an abundance of caution. This does not necessarily mean the medicines were recalled.”
In the FDA Q & A article, one question that is addressed is whether or not a person should stop taking ranitidine medicines. The following answer was given,
FDA does not have scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines at this time...
Patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine may consider using other OTC products approved for their condition.
The FDA has provided a list of other options to take instead of Zantac (ranitidine) that are used for the same medical purpose: Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), or Prilosec (omeprazole)
The September FDA Statement on this issue warned about NDMA's classification as a "probable human carcinogen (a substance that could cause cancer)". This sparked the filing of lawsuits for some people who have been diagnosed with specific cancers possibly related to the use of ranitidine medicines, those cancers being: stomach, colon, rectal, bladder, kidney, and pancreatic. You can refer to our November 2019 article, "Zantac FDA Warning In September 2019 Leads To Lawsuits For Patients Diagnosed With Cancer", for more information.
Details on Zantac (Ranitidine) Recalls
By visiting the FDA Drug Recalls page on their website, you can find the Companies (Drug Brand Names) and Product Description for recalled Zantac / Ranitidine medicines since September 23, 2019:
• Amneal Pharmaceuticals, LLC: Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup 15 mg/mL
• Precision Dose Inc.: Ranitidine Oral Solution, USP 150 mg/10 mL
• GSMS, Inc.: Ranitidine HCl 150mg and 300mg Capsules
• American Health Packaging: Ranitidine Liquid Unit Dose Cups
• Aurobindo Pharma USA, Inc.: Ranitidine
• Lannett Company, Inc.: Ranitidine Syrup 15mg/mL
• Novitium Pharma: Ranitidine Hydrochloride Capsules 150 mg and 300 mg
• Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s, Kroger, Walgreens, and others): Ranitidine Tablets & Capsules
• Perrigo Company plc: Ranitidine (all pack sizes)
• Apotex Corp.: Ranitidine Tablets 75mg and 150mg
• Sandoz Inc.: Ranitidine Hydrochloride Capsules
• Sanofi: Zantac 150, Zantac 150 Cool Mint, Zantac 75 (OTC Products)
What Will the FDA Do Now?
A December 5, 2019 FDA Statement, "Statement from Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S.", gives the following insight,
The FDA will continue to investigate the source of these impurities, but it is important to note that there are multiple reasons why NDMA can be present in drugs. Previously, we found the source of NDMA can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged. As food and drugs are processed in the body, nitrosamines, including NDMA, can be formed. The FDA continues to test and research possible sources for the several drugs found to contain NDMA.
Our law firm will continue to monitor the Zantac (ranitidine) situation and how the FDA handles this issue from here on. We will share any new or relevant information, especially regarding the drug's possible relation to specific cancers.
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