There’s been a lot in the news in recent months about the drug Zantac (ranitidine hydrochloride), and almost every day, even more, disturbing news about Zantac is coming to light. The Jeffcoat Firm in Columbia, South Carolina, understands how confusing some of that information may be, so here’s what you need to know about the Zantac and the recall.
What is Wrong With Zantac?
The online Connecticut pharmacy, Valisure, tests medications regularly for quality and consistency problems. During their testing of Ranitidine (Zantac), their company found very high levels of NDMA “in every lot tested, across multiple manufacturers and dosage forms of the drug Ranitidine.”
NDMA is a chemical that the Food and Drug Administration, the Environmental Protection Agency, and the World Health Organization all have classified as a substance that can cause cancer.
The results of the tests by Valisure were in line with other studies from such places as Stanford University that found the NDMA in Zantac was more than likely due to the “inherent instability” of the Ranitidine molecule.
In June of 2019, Valisure reported its findings to the Food and Drug Administration. Three months later, Valisure filed a citizen’s petition that urged the Food and Drug Administration to recall Zantac and stop all sales.
Was Zantac Recalled by the Food and Drug Administration in 2019?
The Food and Drug Administration did not immediately issue a recall in 2019 but rather warned the public that the testing of Zantac contained a known cancer-causing chemical, N-nitrosodimethylamine (NDMA) at levels more than 3,000 times the legal daily intake limit.
Even though the Food and Drug Administration didn’t take action and recall Zantac, retail stores such as CVS, Walmart, and Walgreens stepped up and pulled Zantac from their shelves.
Additionally, generic drug makers of Zantac, Sandoz, GSK, and Apotex issued their own recalls. According to the Food and Drug Administration, there’s a difference between a market withdrawal and a recall.
A market withdrawal has to do with a minor violation. It isn’t subject to legal action by the Food and Drug Administration. Whereas, a recall is the removal of the product that the Food and Drug Administration thinks violates the laws it administers.
Then, in January of 2020, the research laboratory at Emery Pharma also filed a citizen’s petition to have Zantac recalled. They noted in their petition that Ranitidine is a time and temperature-sensitive pharmaceutical product that develops into NDMA when it is exposed to heat. In their press release, Emery Pharma said: “Exposure to high temperatures is a common occurrence during transportation and storage, and is of specific concern to Ranitidine as there currently are no requirements for the drug to be shipped in temperature-controlled conditions and/or stored under refrigeration.”
Zantac Recall 2020
Finally, on April 1, 2020, the Food and Drug Administration made an announcement that all manufacturers of Zantac and the generic forms of Zantac are to withdraw them from the market effective immediately.
During their investigation, the Food and Drug Administration found that the NDMA in some Zantac drugs “increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels…”
What Zantac Is Included in the Recall?
Below is a list of all of the companies that have issued Zantac (Ranitidine) recalls even before the Food and Drug Administration issued their “market withdrawal” announcement.
- American Health Packaging
- Amneal Pharmaceuticals
- Aurobindo Pharma USA
- Apotex Corp. (this includes over-the-counter Ranitidine tablets 75 mg and 150 mg,
labeled by Walgreens, Walmart, and Rite-Aid)
- Appco Pharma
- Denton Pharma (dba Northwind Pharmaceuticals)
- Reddy’s Laboratories (this includes Zantac over-the-counter OTC medicines
labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger)
- GlaxoSmithKline (GSK)
- Glenmark Pharmaceuticals
- Golden State Medical Supply
- Lannett Company
- Novitium Pharma
- Perrigo Company
- Precision Dose
If you or a loved one has taken Ranitidine (Zantac) and developed cancer, you must have an attorney who has experience going against major drug companies. The Zantac cancer attorneys at The Jeffcoat Firm in Columbia, South Carolina, have the experience necessary to hold large corporations accountable for not revealing the dangers of certain consumer products.
The attorneys at The Jeffcoat Firm have the knowledge, experience, and dedication to be a strong advocate for you or your loved one who has developed cancer after taking Ranitidine (Zantac). We offer a free consultation where we will listen carefully to the details of your individual case and advise you about the legal steps that should be taken to protect your rights and get you all the monetary compensation you deserve.