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Attorney General Merrick Garland announced that the arrests and charges, spread over the past few weeks, involved various scams defrauding insurance companies, patients, and Medicare. Authorities have seized over $230 million in assets. A significant case involved a $900 million scam in Arizona, where clinic owners Alexandra Gehrke and Jeffrey King allegedly received $330 million in kickbacks for unnecessary wound treatments billed to Medicare.

Memory updated Date: June 24, 2024 Glenmark Pharmaceuticals Inc., USA has initiated a voluntary nationwide recall of 114 batches of their Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K. The recall affects both 100-count and 500-count bottles and is due to failed dissolution, which could lead to dangerously high potassium levels (hyperkalemia) and associated risks such as irregular heartbeat and potential cardiac arrest.

April 29, 2024: The FDA announced a final rule to ensure the safety and effectiveness of laboratory developed tests (LDTs). This rule clarifies that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) even when manufactured by laboratories. The FDA is phasing out its general enforcement discretion for LDTs over four years, transitioning to greater oversight and targeted enforcement for certain IVD categories.

How to Spot Fake Ozempic In 2023, the FDA seized thousands of counterfeit Ozempic units circulating in the U.S. supply chain, linked to several cases of hypoglycemia. Key Indicators of Counterfeit Ozempic: Lot and Serial Numbers: Avoid products with lot number NAR0074 and serial number 430834149057. Physical Characteristics: A genuine Ozempic pen does not extend in length when setting the dose. Counterfeit boxes may have spelling errors and mismatched batch numbers.

Teleflex and its subsidiary, Arrow International, have initiated a Class I recall of the ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits. This recall, the most serious type issued by the FDA, addresses critical safety concerns that may lead to serious injuries or death.

The CDC has issued a warning about the risks to ADHD patients after a major disruption in the online prescription of Adderall and other stimulants. This follows the indictment of executives from Done Global, an online telehealth platform, on charges of healthcare fraud and improper Adderall distribution. The disruption may affect up to 50,000 patients, worsening the existing shortage of ADHD medications.

Ensuring Safety through Rigorous Oversight The FDA’s Office of Regulatory Affairs (ORA) employs a robust, risk-based approach to safeguard the safety of foods, drugs, and medical products in the United States. This strategy encompasses several key areas: Inspections and Investigations: Regular inspections of food and drug facilities both domestically and internationally. Criminal investigations to tackle fraudulent activities that pose health risks. Laboratory testing of potentially hazardous products.

Overview: Medline Industries, LP has initiated a recall of its Medline Sub-G Endotracheal Tube with Subglottic Suctioning due to serious defects. The FDA has classified this recall as the most severe, indicating that continued use of these devices could result in serious injury or death.

In a recent discussion at the Regulatory Education for Industry (REdI) meeting on May 30, Jill Furman, the director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research (CDER), provided crucial updates and addressed common misperceptions regarding FDA’s drug compliance actions. Furman highlighted several important points: New FDA Web Page: The FDA has launched a new web page aimed at clarifying misperceptions about its drug compliance actions.

The U.S. Food and Drug Administration (FDA) has unanimously recommended an update to the COVID-19 vaccine formula for the upcoming fall booster campaign. This new formula aims to address the JN.1 variant, which is currently the predominant strain causing infections. Unlike previous boosters that targeted multiple variants, this new booster will be monovalent, focusing solely on the JN.1 variant.