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Time of India
a day ago
- Health
- Time of India
Zero-sugar soda cans recalled in the US: FDA cites class II health risk; know how serious it is
A major soda recall is underway following the discovery of thousands of cans of Dr. Pepper Zero Sugar containing regular, full-sugar soda. The mislabeling issue, which impacts multiple southeastern states, has triggered a voluntary recall. The U.S. Food and Drug Administration (FDA) confirmed the recall and has officially categorized it as a Class II health risk. The 'Class II health risk' means that the affected products may cause 'temporary or medically reversible adverse health consequences' if consumed. What's being recalled? According to the FDA, the recall involves 19,203 cases of Dr. Pepper Zero Sugar 12-ounce aluminum cans, sold in 12-pack and 24-pack formats. As per the report, the affected products were distributed to retail locations across Florida, Georgia, and South Carolina. The mislabeling means that while the cans are labeled as "Zero Sugar," they might actually contain full-sugar soda. This presents potential risks for individuals who have conditions such as diabetes, obesity, heart disease, or those simply trying to manage their sugar intake. However , the good news is that the recalled cans can be easily identified by the production code 'XXXXRS05165' and a best-by date of February 16, 2026, printed on the packaging. When did the issue come to light? The issue first came to light when the product's manufacturer, Keurig Dr Pepper, initiated a voluntary recall on May 23, 2025. The FDA then officially listed the incident as a Class II recall on June 5. Per the FDA classification system, a Class II recall occurs when 'use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.' In a statement to ABC News, Keurig Dr Pepper said the affected soda cans were produced at a PepsiCo bottling facility that is licensed to manufacture certain Keurig Dr Pepper products. The company added that 'the recalled product has been removed from stores' and did not report receiving any complaints or reports of illness related to the error. Typically, Dr. Pepper Zero Sugar is made using aspartame, a sugar substitute, to offer a low-calorie alternative to sugary sodas. Consuming large amounts of sugar when expecting a sugar-free product could be particularly risky for people with blood sugar sensitivities. The Centers for Disease Control and Prevention (CDC) warns that added sugars in beverages like sodas are a major contributor to health conditions such as type 2 diabetes, high blood pressure, and obesity. Source: Canva Consumers are advised not to consume the product if it matches the recalled batch. You can report any adverse reactions or quality issues to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. How the FDA classifies recalls based on health hazards When a product is recalled, the U.S. Food and Drug Administration (FDA) assigns it a classification to indicate the level of health risk it poses to the public. These recall classifications—Class I, II, or III—are based on the potential severity of the health consequences associated with using or being exposed to the product. Class I Recall This is the most serious type of recall. It applies to situations where there is a reasonable probability that the use of or exposure to the product will result in serious health problems or even death. These recalls often involve issues like contamination, incorrect labeling on life-saving drugs, or malfunctioning medical devices. Class II Recall This classification is used when the product may cause temporary or medically reversible health effects, but the risk of serious injury is considered remote. These recalls may involve products with minor labeling errors or products that fail to meet quality standards but are not life-threatening. Class III Recall A Class III recall is issued when the product is unlikely to cause any adverse health effects. These are generally administrative in nature and may involve minor violations, such as packaging defects or slight deviations from labeling requirements, that do not pose a health hazard. One step to a healthier you—join Times Health+ Yoga and feel the change
Yahoo
25-04-2025
- Business
- Yahoo
FDA Sounds Alarm on ‘Counterfeit' Ozempic—What to Know
The U.S. Food and Drug Administration (FDA) and drug manufacturer Novo Nordisk are warning consumers about 'counterfeit' Ozempic found outside the authorized drug supply chain. The contents of the counterfeit drugs have yet to be determined, but potentially unsterile needles may pose a risk of infection. Here's how to tell if you may have counterfeit Ozempic and what to do. Amid the various drug and food recalls this year, the U.S. Food and Drug Administration (FDA) has made another announcement that may affect many consumers taking the popular type 2 diabetes drug, Ozempic. The FDA and Novo Nordisk (the manufacturer of Ozempic) issued press releases early last week regarding several hundred units of 'counterfeit' Ozempic injection 1 mg found and distributed outside the authorized drug supply chain throughout the United States. The FDA noted in their press release that the 'U.S. FDA seized the identified counterfeit products' on April 9, 2025. However, the FDA urges patients, healthcare professionals, pharmacies, and wholesalers to confirm that the Ozempic products in their possession are legitimate and to avoid using, selling, or distributing affected products. The affected Ozempic injection 1 mg feature lot number PAR0362 and illegitimate serial numbers beginning with the first eight digits 51746517. Lot number PAR0362 is authentic, authorities confirm, and is only counterfeit if combined with an illegitimate serial number. The affected products contain counterfeit visual features. 'Neither Novo Nordisk nor FDA can confirm the contents or quality of the counterfeit product, which may present a safety risk for patients who use the counterfeit product,' Novo Nordisk explained in a press release. Further investigation into the contents of the products is underway, but analysis found that 'needles from the samples are counterfeit' and cannot be guaranteed to be sterile, meaning that use of the counterfeit product poses an increased risk of infection, per the FDA. The FDA stated that the agency is aware of five 'adverse events' related to the counterfeit lot. However, none of the events were 'serious' and have been 'consistent with known common adverse reactions to authentic Ozempic, which are nausea, vomiting, diarrhea, abdominal pain, and constipation.' If you believe you may possess counterfeit Ozempic, Novo Nordisk encourages you to report the product by calling their customer care team at 1-800-727-6500 (8:30 a.m. to 6:00 p.m. EST, Monday through Friday) and to report it directly to the FDA here. If you experience any side effects, report them to the FDA's MedWatch Safety Information and Adverse Event Reporting Program as well as to Novo Nordisk, using the same customer care number above. You Might Also Like Can Apple Cider Vinegar Lead to Weight Loss? Bobbi Brown Shares Her Top Face-Transforming Makeup Tips for Women Over 50
Yahoo
15-04-2025
- Health
- Yahoo
FDA warns of fake Ozempic Type 2 diabetes injection drugs
April 14 (UPI) -- The U.S. Food and Drug Administration on Monday warned consumers and pharmacies that fake versions of Ozempic, a drug to treat Type 2 diabetes, have been found in the United States. Novo Nordisk, the Danish-headquartered manufacturer, informed the FDA on April 3 that counterfeit 1-milligram injections of semaglutide were being distributed outside its authorized supply chain. The drug is sold in 0.5 mg, 1 mg and 2 mg doses, and are injected weekly. The fake products likely entered the market through unauthorized distributors or resellers, the agency and company said. Counterfeit products -- labeled with lot number PAR0362 and serial numbers starting with the first eight digits 51746517 -- were seized by the FDA on Wednesday. Lot number PAR0362 is authentic, the company said. Only when the lot number is coupled with the eight digits 51746517, it is counterfeit. The FDA and Novo Nordisk are testing the fake products to identify whether they're safe. The agency said six adverse event reports linked to the lot were linked to the lot but none appear to be associated with the counterfeit product. The drug normally can have side effects. Patients are asked to obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product for any signs of counterfeiting. People in possession of the fake product are urged to call Novo Nordisk customer care at 800-727-6500 Monday through Friday from 8:30 a.m. to 6 p.m. EDT and report it to the FDA's criminal activity division's website. Side effects can be reported to FDA's MedWatch Safety Information and Adverse Event Reporting Program (800-FDA-1088 or as well as to Novo Nordisk, at 800-727-6500. Ozempic is a glucagon-like peptide 1, or GLP-1, receptor agonist to improve glycemic control in adults with Type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events. Ozempic has been used off-label by people seeking to lose weight. The retail price is $998 for four injections to be used weekly. Wegovy is the company's weight loss drug, which also is an injectable. In 2024, Novo Nordisk's Ozempic generated nearly $17 billion in sales and Wegovy brought in around $8 billion. Eli Lilly's Type 2 diabetes drug is Mounjaro and the weight-loss version is Zepbound.
