Ranitidine is a medication used to treat heartburn and stomach ulcers. It has been recalled by the FDA due to an increased risk of death or serious side effects.
The is ranitidine back on the market is a question that is asked often. Ranitidine has been recalled, but it has not yet been removed from the market.
Following the discovery of contamination with a potential carcinogen, ranitidine, including its brand-name form Zantac, has been recalled. Many individuals who use these drugs may be asking when ranitidine was recalled. What was the reason for the recall of ranitidine? What brands of ranitidine have been recalled? Is it safe to use ranitidine?
The US Food and Drug Administration reported on September 13, 2019, that certain batches of ranitidine had been contaminated with NDMA (N-nitrosodimethylamine), a potential human carcinogen that is produced as a byproduct of various manufacturing processes.
Sandoz, a generic subsidiary of the pharmaceutical firm Novartis, manufactures ranitidine. In the United States, Sandoz and another generic manufacturer, Apotex, have recalled their generic ranitidine medicines.
Sanofi is the manufacturer of the brand-name Zantac. Sanofi voluntarily recalled over-the-counter Zantac on Oct. 18, 2019, due to concerns about NDMA contamination.
Both brand-name Zantac and generic ranitidine are no longer available at CVS, Walgreens, or Walmart.
What Brands of Ranitidine Have Been Recalled?
What brands of ranitidine have been recalled? The FDA has updated its information on ranitidine’s safety. Several firms have issued recalls for ranitidine in the past year, and the FDA asked that all ranitidine medications be removed off the market in early April.
The FDA first disclosed the ranitidine contamination in September of this year. Several generic medicine manufacturers, including Sandoz and the manufacturers that provide ranitidine to CVS, Rite Aid, Walmart, and Walgreens, have issued voluntary recalls since the announcement.
When was Ranitidine withdrawn off the market?
So, when was ranitidine withdrawn off the market? The response varies. Several ranitidine items have been recalled or withdrawn from store shelves to date: the FDA keeps track of which ranitidine products have been recalled on a regular basis.
- Sandoz (Novartis’ generic arm) issued a voluntary recall of all ranitidine hydrochloride capsules in the United States on September 23.
- Apotex voluntarily recalled all 75mg and 150mg ranitidine pills throughout the country on September 25.
- On Oct. 18, Sanofi announced a recall of all Zantac OTC (over-the-counter) products in the United States.
- Perrigo ordered a global voluntary recall of all of its ranitidine medicines on October 23, 2019.
- On the same day, Dr. Reddy’s announced a voluntary recall of all of its ranitidine products in the United States. Several Dr. Reddy’s products are available at Walgreens, Member’s Mark (Sam’s Club), CVS, Kroger, and Equate, among others (Walmart).
- The Lannett Company issued a recall of all ranitidine syrup (15mg/ml) on October 25, 2019.
- Novitium Pharma also issued a voluntary nationwide recall of all 150mg and 300mg ranitidine capsules in the United States on October 25.
- On November 6, 2019, Aurobindo Pharma issued a recall for 38 batches of ranitidine pills, capsules, and syrup.
- On November 8, Amneal Pharmaceuticals issued a recall for ranitidine pills and syrup (the FDA announcement was published on Nov. 22).
- Ranitidine hydrochloride pills were recalled by Golden State Medical Supply on Nov. 15.
- Precision Dose announced a recall for five batches of ranitidine oral solution on November 19.
- On December 17, 2019, Glenmark Pharmaceuticals announced a ranitidine 150 mg and 300 mg recall.
- Denton Pharmaceuticals issued a recall of its ranitidine pills on Jan. 6, 2020 (announced by the FDA on Jan. 8), including a ranitidine 150 mg recall and a ranitidine 300 mg recall.
- Appco Pharmaceuticals recalled its ranitidine pills on January 7, 2020.
- On February 27, 2020, American Health Packaging announced a ranitidine 150 mg recall.
- The FDA recommended that all ranitidine medications be taken off the market on April 1, 2020.
Is it possible that ranitidine has been tainted?
So, why was ranitidine recalled to begin with? These medicines may be tainted, according to ranitidine tablet testing. n-nitrosodimethylamine is a contaminant discovered in ranitidine (NDMA). NDMA is a potential human carcinogen that is produced as a byproduct of a variety of industrial operations, including the production of jet fuel. It has previously been discovered in valsartan and other ARB blocker medicines as a contaminant. Although NDMA is present in the environment and it is difficult to completely prevent all exposure to the pollutant, long-term exposure may have negative health effects.
Ranitidine has been recalled after the FDA urged pharmaceutical firms to recall tablets if NDMA levels were found to be higher than 0.32 parts per million during testing. This has been found to be the maximum amount of NDMA that may be consumed in one day. Several manufacturers have recalled contaminated ranitidine owing to the potential hazards of greater ingestion levels.
Drug firms should recall ranitidine products if they contain more than 96 nanograms of NDMA per daily dosage, according to the FDA’s website. The FDA said that the daily permissible consumption of NDMA is 96 nanograms per day. However, new study on the nature of NDMA contamination has shown that determining the quantity of NDMA in ranitidine may be difficult. Since then, the FDA has taken a firmer position, requesting a voluntary recall of all over-the-counter ranitidine on April 1, 2020, in order to remove it from the market promptly owing to the NDMA risk.
According to CBS News, NDMA may be produced when the heartburn medication is cooked beyond a specific temperature, according to a research performed by Emery Pharma. “NDMA in this instance… is not a contaminant in the medication; it’s being produced from the drug itself,” said researcher Ron Najafi of the phenomenon.
According to CBS, Emery Pharma’s study revealed that the drug’s NDMA concentration increased somewhat while stored at ambient temperature and increased rapidly when exposed to greater heat. The NDMA concentration of ranitidine increased to 25 nanograms after 12 days at room temperature, according to reports. However, when ranitidine was heated to 158 degrees Fahrenheit, the NDMA concentration soared to 143 nanograms, much above the FDA’s daily permissible consumption limit of 96 nanograms.
More study is required to properly understand the connection between ranitidine and NDMA, according to reports. For example, scientists aren’t sure whether the medication has to be kept cold to avoid converting to NDMA, or if it can convert to NDMA after it’s been consumed.
Is it necessary for me to stop taking Zantac?
The FDA is still testing generic and brand-name versions of ranitidine in both prescription and over-the-counter strength. The FDA is not advising people to cease using the medication at this time.
What may I use instead of Zantac to help with acid reflux?
Tagamet (cimetidine) and Pepcid (famotidine) are two additional over-the-counter medicines that decrease the symptoms of stomach acid, such as acid reflux and heartburn, in the same way that Zantac does.
What Is Zantac and What Is It Used For?
Zantac (ranitidine) is a histamine-2 (H2) blocker that lowers stomach acid production while also counteracting the corrosive effects of stomach acid that cause heartburn and acid reflux. H2 blockers such as Tagamet and Pepcid are also available.
Patients with peptic ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome are often given the drug. Every year, about 15 million individuals in the United States use prescription forms of the medication, with millions more presumably using a low-dose over-the-counter equivalent, such as Zantac.
What Are the Consequences of Taking Ranitidine?
Ranitidine, like any other drug, has the potential for adverse effects. The following are the most frequent ranitidine adverse effects:
- Headache
- Constipation
- Diarrhea
- Vomiting and nausea
- Pain or discomfort in the stomach
The following are some of the most severe ranitidine adverse effects:
- Your liver is inflamed (symptoms include yellowing of skin or eyes, dark urine)
- Changes in the way your brain works (confusion, agitation, depression, hallucinations)
- Heart rate that is abnormal (fast heart rate, tiredness, shortness of breath)
However, it was information from the US Food and Drug Administration that indicated that ranitidine may be tainted with NDMA that prompted the current spate of recalls, not these ranitidine adverse effects.
What Is NDMA and How Does It Work?
NDMA is a result of the breakdown of dimethylhydrazine, a component of jet fuel, as well as a byproduct of other industrial production processes, according to the World Health Organization. Some herbicides include NDMA, which may also be a result of water chlorination, particularly if ammonia is not removed first.
NMDA may also be a result of tanneries, rubber and tire manufacturers, seafood processing facilities, and dye producers, according to the US Environmental Protection Agency (EPA). Inhaling cigarette smoke, eating smoked or cured meats and seafood, drinking malt drinks that may contain low amounts of nitrosamines produced during processing, and eating smoked or cured meats and fish may all expose you to NDMA.
What Are the Risks of Taking Ranitidine That Has Been Contaminated?
NDMA exposure has been linked to the development of tumors and cancer in studies. Exposure to NDMA-contaminated ranitidine may cause severe health problems, such as stomach cancer or bladder cancer. Other NDMA adverse effects include nausea, vomiting, fever, stomach cramps, disorientation, and renal and lung damage. Patients using ranitidine for heartburn should speak with their primary care physician about switching to a different medication until the source of the contamination in ranitidine tablets is identified.
While the FDA has not recommended that all patients cease taking ranitidine, it has said that individuals should be aware of the possible risk and speak with their doctor if they have any concerns. If you’re using an over-the-counter form of ranitidine, you may want to consider switching to a different authorized drug.
Victims of tainted or recalled ranitidine who have been diagnosed with cancer may be entitled to engage a competent attorney and launch a class action lawsuit against the medication makers.
What Cancers Have Been Linked to NDMA Exposure?
NDMA has been linked to an increased risk of stomach or colorectal cancer, according to the World Health Organization. The liver is very toxic to NDMA.
Is NDMA the same substance that was previously discovered in Valsartan blood pressure medications?
Yes, some batches of valsartan and other blood pressure medicines were discovered to be tainted with NDMA.
In comparison to Valsartan, how much NDMA has been discovered in Zantac?
The FDA is currently performing testing, but the quantity discovered is extremely tiny, according to the agency. The FDA said at the time of the valsartan NDMA finding that if 8,000 patients took the maximum daily dosage of valsartan for four years, one extra cancer diagnosis would occur.
“Although NDMA may cause damage in high quantities, the levels the FDA is detecting in ranitidine from early testing barely exceed those you would expect to find in typical foods,” Dr. Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research, said in a statement.
Can I File a Lawsuit Against Ranitidine?
You may be eligible to file a ranitidine recall case and seek compensation if you or someone you know has developed stomach cancer or bladder cancer as a result of exposure to ranitidine. Of course, filing a ranitidine recall lawsuit will not relieve the agony and suffering caused by a cancer diagnosis or other NDMA side effects, nor will it bring a loved one back to life, but it will assist to lessen the financial burden imposed by medical bills, missed earnings, and other costs.
Top Class Actions has prepared the groundwork for you by connecting you with an experienced attorney. Filing a ranitidine recall lawsuit can be a daunting prospect, especially in the wake of a cancer diagnosis, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. A lawyer can assist you in determining if you have a claim, navigating the intricacies of litigation, and maximizing your possible reward.
The ranitidine cancer is a medication that has been recalled. There are many different types of ranitidine, so it can be difficult to know which one has been recalled.
Frequently Asked Questions
Which brands of ranitidine have been recalled?
Ranitidine is a type of medication that is used to treat ulcers. It has been recalled by the FDA due to concerns about its potential for causing serious side effects, including death. The recall was issued in December 2018 and it affects four brands of ranitidine: Zantac, Rani-Tol, Pepcid AC, and Tagamet HB.
Is all ranitidine being recalled?
Yes, all Ranitidine is being recalled.
What can I take instead of ranitidine?
Ranitidine is a prescription medication that can be replaced by over-the-counter medications such as Tylenol, ibuprofen or acetaminophen.
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