Choco Lake Diamond Twist Chocolate Recalled Due to Aflatoxin Contamination
The Canadian Food Inspection Agency has issued a recall for Choco Lake Diamond Twist brand Milk Chocolate with Kunafa Pistachio Paste Flavor due to aflatoxin contamination. The recall affects products distributed in Ontario, with specific lot codes and expiry dates identified.
Venlafaxine XR Recall
Health Canada has issued a Type II recall for VENLAFAXINE XR 75mg capsules due to dissolution testing being out of specification. Retailers are instructed to remove the affected product from shelves. Consumers should consult a healthcare provider before discontinuing use.
Worthy Crumb Pastry Co. Scones Recalled Due to Mould
The Canadian Food Inspection Agency has issued a recall for The Worthy Crumb Pastry Co. brand Cheddar and Chive Artisan Scones due to mould contamination. The product was distributed nationally, and consumers are advised not to use or distribute the affected product.
HHS OIG: Over $15 Million in Improper Medicare Payments for Non-Emergency Services
The HHS Office of Inspector General (OIG) reported that Medicare improperly paid physicians $922,524 and potentially $14.2 million to hospitals for services billed with emergency department procedure codes but rendered at non-emergency sites. The OIG recommends recovery of improper payments and improved claims processing controls.
Vicks Sinus Steam Inhaler Recall
Health Canada has issued a recall for the Vicks Sinus Steam Inhaler (VIH200CV1) because it was distributed without the required Medical Device License. Consumers are advised to retain the product and contact Kaz USA Inc. for further instructions.
Chikungunya Vaccine IXCHIQ: Risks for Frail Seniors 65+
Health Canada has issued updated safety information regarding the chikungunya vaccine IXCHIQ. Medically frail individuals aged 65 and older may be at increased risk of serious adverse reactions. Healthcare professionals are advised to carefully assess risks and benefits for this demographic.
Ketorolac Recalled Due to Weight Out of Specification
Health Canada has issued a Type II recall for Ketorolac (DIN 02245821) manufactured by AA Pharma Inc. due to weight being out of specification in affected lots VE3252 and VE3251. Retailers are instructed on the recall process and consumers are advised to consult healthcare providers.
FDA Q&A on Biosimilar Development and BPCI Act
The FDA has reissued its final guidance on biosimilar development and the BPCI Act, solely to withdraw three specific Q&As (I.8, I.10, and I.19). The agency is continuing to evaluate other Q&As for potential updates.
FDA Draft Q&As on Biosimilar Development and BPCI Act
The FDA has issued a draft guidance document providing updated answers to common questions regarding biosimilar development and the Biologics Price Competition and Innovation Act (BPCI Act). This revision replaces a previous draft and focuses on specific Q&As related to the abbreviated licensure pathway for biological products.
FDA Guidance: Flavored ENDS Premarket Applications
The FDA has issued guidance to assist with premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS). This guidance, intended to improve submission and review efficiency, focuses on considerations related to youth risk. The document is non-binding and aims to inform potential future rulemaking.
FDA Warning Letter to Ivim Services LLC for Misbranded Drugs
The FDA issued a warning letter to Ivim Services LLC for introducing misbranded compounded semaglutide and tirzepatide products into interstate commerce. The agency found that Ivim's website made false or misleading claims, suggesting Ivim was the compounder when it was not, violating the Federal Food, Drug, and Cosmetic Act.
FDA Warning Letter to Good Girl LLC for False Claims
The FDA issued a warning letter to Good Girl LLC (dba GoodGirlRX) for making false and misleading claims on its website regarding compounded semaglutide and tirzepatide products. The company claimed the products were 'FDA-approved' and that GoodGirl RX was the compounder, which the FDA states is false and misbrands the drugs.
FDA Warning Letter to Peaks Curative for False Claims
The FDA issued a warning letter to Peaks Curative, LLC for making false and misleading claims on its website regarding compounded semaglutide products. The agency found that the company misrepresented its compounding practices and implied FDA approval for products that are not FDA-approved, leading to misbranding violations.
FDA Warning Letter to PharmaZee for False Claims
The FDA issued a warning letter to PharmaZee for making false and misleading claims on its website regarding compounded semaglutide and tirzepatide products. The agency found that PharmaZee misrepresented itself as the compounder and implied FDA approval for these unapproved drugs, violating the Federal Food, Drug, and Cosmetic Act.
FDA Warning Letter to Refills Health for False Claims
The FDA issued a warning letter to Refills Health, LLC for making false and misleading claims on its website regarding compounded semaglutide products. The agency found that the company misrepresented itself as the compounder and made unsubstantiated claims such as 'clinically proven,' leading to the products being considered misbranded under the FDCA.
FDA Warning Letter to Lean Rx Inc. dba SkinnyRx
The FDA issued a warning letter to Lean Rx Inc. dba SkinnyRx for misbranding compounded semaglutide and tirzepatide products. The agency cited false or misleading claims on the company's website regarding the compounding of these drugs and their relation to FDA-approved medications.