The Recall Guy

?? 2024 Product Recalls Expected to Hit Six-Year High ?? This year, the U.S. is on track to reach a record-high in product recalls, with experts anticipating a spike across various categories—consumer goods, food, drugs, and medical devices. With recalls soaring, understanding how these alerts impact our daily lives, business operations, and overall safety is more important than ever. Why Are Recalls Rising? Several factors are contributing to this rise: ? Increased Regulatory Oversight: With consumer safety at the forefront, the FDA and other regulatory bodies have increased scrutiny, catching issues earlier and more often. ? More Complex Supply Chains: As products are sourced and assembled globally, even minor issues can cause widespread impacts. ? Heightened Public Awareness: With social media and news outlets amplifying alerts, more consumers are informed and proactive in reporting issues. ?? How to Protect Yourself and Your Business If you’re a consumer, it’s critical to stay informed about the products you bring into your home, especially those you rely on for health and wellness. Businesses, on the other hand, need to be prepared with quick response strategies, ensuring that recalls are managed responsibly and that customers remain safe and confident in their purchases. To simplify this process, I launched The Recall Guy newsletter. It’s designed to filter through the overwhelming amount of recall data and bring you only the most relevant, high-impact alerts, directly to your inbox. Whether it’s a product in your pantry, your medicine cabinet, or something in your business inventory, The Recall Guy has you covered. Who Should Subscribe? Consumers wanting a quick way to stay informed without searching dozens of websites. Small Businesses needing to keep their customers safe and stay compliant with industry standards. Health & Wellness Advocates who prioritize transparency and safety in their products. This year’s statistics remind us how crucial it is to have fast, reliable information. Recalls affect not just our wallets but our safety and peace of mind. ?? Join The Recall Guy today to stay informed and stay safe www.TheRecallGuy.com

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?? Milk in Butter? It's About More Than Common Sense There's been a lot of press about the recent recall of Kirkland Signature Sweet Cream Butter because it didn't explicitly state that cream contains milk. Many people are understandably poking fun at the situation, questioning if we need warning labels stating that beef contains cow! However, as humorous as this may seem, it highlights a critical point: manufacturers have a responsibility to clearly and accurately label their products. While it may seem obvious to many that butter contains milk, allergies are a serious issue. The CDC notes that milk is a leading cause of severe allergic reactions in the United States. This recall serves as a reminder to all manufacturers that clear labeling is essential, even for seemingly obvious ingredients. It's not about insulting anyone's intelligence; it's about ensuring the safety and well-being of all consumers. Let's advocate for transparency and accountability in food labeling.

?? China Drafts New Law to Regulate Medical Devices China is drafting a new top-level law to regulate medical devices, aiming to streamline the currently fragmented regulatory framework. This draft law, which underwent public consultation until September 28th, will cover all stages of a medical device's life cycle: research and development, manufacturing, distribution, and sales. One key highlight of this new law is the provision allowing for the transfer of medical device registration certificates. This change addresses a significant challenge faced by companies, especially those developing expensive medical devices. Currently, if a company lacks the resources to bring a device to market, even if another company is willing and able to continue development, the registration certificate cannot be transferred. This forces companies to either acquire the original company or repeat costly clinical trials, hindering innovation and market access. The NMPA, while supporting the transfer, emphasizes safety and effectiveness, prohibiting the transfer of certificates for devices that are expired, invalid, obsolete, refurbished, or fail inspection. Another important aspect of the draft law is the increased responsibility placed on local legal representatives for imported medical devices. They will now bear joint liability with the registrants and filers, ensuring greater accountability and compliance. This measure is expected to improve enforcement, as it can be challenging for the NMPA to exert jurisdiction over foreign entities. Local legal agents will play a crucial role in post-approval compliance, including annual reporting, adverse event monitoring, product recalls, and coordinating with the NMPA on overseas inspections. This new law comes amidst a significant increase in medical device registrations in China. In 2023, initial registration applications surged by 34% compared to the previous year, and the total number of registrations has more than doubled since 2018. While encouraging this growth, the NMPA is also stepping up efforts to combat malpractice in the medical device market. This includes increased investigations and a proposal to reward whistleblowers who expose illegal activities.

?? Important Vitamin C Recall Due to Potential Risk of Death ?? The FDA has issued a Class I recall for a specific lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL due to the presence of glass particulate matter. This is the highest risk classification indicating "a reasonable probability that a product could cause serious injury or death." The recall, initiated by STASKA Pharmaceuticals, Inc. on October 16, was updated on November 7 with the higher risk classification. The contaminated products were distributed to healthcare providers between July 31, 2024, and August 27, 2024, and have an expiration date of December 31, 2024. The lot number associated with the recall is SP2400058. While the product label instructs healthcare professionals to visually inspect for foreign matter before administering, the FDA advises that using the contaminated product could lead to serious consequences. "The particulate matter could travel through and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death." The severity of potential side effects could depend on several factors, including the size and number of particles. If you have the recalled vials, stop using them and contact STASKA Pharmaceuticals directly for a return and replacement. You should also contact your doctor if you have concerns about potential adverse effects. This recall highlights the importance of vigilance in healthcare settings, even with commonly used products like vitamin C injections.

?? Costco Butter Recall Due to Undeclared Allergen ?? Continental Dairy Facilities Southwest LLC has issued a recall of nearly 80,000 pounds of Kirkland Signature butter due to a potential missing allergy statement on the packaging. The recall affects both salted and unsalted varieties of the butter, which were distributed in Texas. The FDA classified the recall as Class II, meaning that while the probability of serious adverse health consequences is remote, consuming the product may cause temporary or medically reversible adverse health consequences. The recall was initiated on October 11 and classified on November 7. The issue stems from the packaging potentially missing the "Contains Milk" statement, even though cream is listed as an ingredient. This omission poses a risk to individuals with milk allergies, as they may unknowingly consume the product and experience allergic reactions. Milk is one of the eight major allergens, and milk allergies are particularly common in children. Symptoms can range from mild (wheezing, vomiting, hives, and digestive problems) to severe, including life-threatening anaphylaxis. The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 mandates that food product labels in the U.S. clearly identify the source of any major food allergen to protect consumers.