The date of Zantac Recall is September 7th, 2021. In a letter from the US FDA to the drug company Cephalon, the agency notified the company that they have identified a potential issue regarding the combination of Zantac and ranitidine. Specifically, the FDA asked the company to "cease distribution of Zantac and ranitidine" and request that they" institute a corrective action plan". It is important to note that this recall does not affect currently sold Zantac products. However, Zantac will begin a voluntary recall when the report of the incident becomes public. Continue reading below to learn more.
Zantac is an acid reducer/task-specific drug that treats gastroesophageal reflux disease with the dual action of antispasmodic and non-antispasmodic agents. Zantac was marketed as a generic version of ranitidine (PRI), a prescription drug used in the treatment of gastroesophageal reflux disease and its associated problems, such as occasional heartburn and nausea. Ranitidine, like other antispasmodic drugs, affects the muscles of the esophagus and stomach and increases lower esophageal sphincter (LES) efficiency.
However, when Zantac was sold without a prescription to individuals who were not qualified to use it for heartburn or any other medical problems, it posed a risk for people who use or abuse it for non-medical purposes. Individuals prescribed ranitidine to reduce their regular medication to control frequent heartburn or those with a history of GERD (gastroesophageal reflux disease) experienced serious side effects when taking generic Zantac, including: severe burning, difficulty breathing, excessive sweating, dizziness, confusion, nausea, and upset stomach. Individuals with liver disease or diabetes are not advised to take Zantac because it can adversely affect their blood sugar levels.
Ranitidine is marketed under several names, including Zantac, Reglan, Zantac plus H2 blocker, Zantac extended release, and Reglan extended release. Ranitidine is available without a prescription in the United States, United Kingdom, Canada, Australia, Germany, Ireland, Italy, Japan, Singapore, Switzerland, and New Zealand. Some areas in the United States, including New York, Massachusetts, and Wisconsin, have restrictions on the sale of generic ranitidine. In these areas, individuals may be able to purchase the generic drug by showing valid ID, making prior written promises to the pharmacy about the intended use, or having a physician order the generic Ranitidine for the patient's personal medical benefit.
A member of the third category, generic ranitidine, caused a recall of its product in March of 2021 because one of its main ingredients, guaranine, was thought to be a potential cause of cancer-causing agents. It is unclear whether guaranine was included in the ingredient mix of the Zantac products that were recalled. The FDA sent warning letters to more than two dozen food manufacturers and two dietary supplement companies that produce generic ranitidine, advising that the agency will ban the products if a connection between the ingredient and cancer is found. Since the FDA has not issued a recall on the product in question, it is unknown what actions it will take to remedy the situation. Click to catch more insight.
In May of2019, Zantac will be releasing an over-the-counter supplement called Zantac Q10 Plus. The supplement will contain all the antioxidants the Zantac family offers. However, it will offer a more targeted approach to Zantac's main antioxidant, vitamin A. The new supplement will be made available to consumers to avoid the two other Zantac recalls. Zantac will continue to monitor the situation and evaluate any additional potential threats to the health and nutritional content of its lineup.
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