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Idaho Pharmacy Board: Ivermectin OTC Update

The Idaho Board of Pharmacy has issued an update regarding the over-the-counter availability of Ivermectin. This notice clarifies regulatory standing following legislative changes, referencing Senate Bill 1211.

Idaho Board of Pharmacy: Expedited Temporary Licensure Pathway for Rite Aid Closure

The Idaho Board of Pharmacy has established an expedited temporary licensure pathway due to the closure of Rite Aid pharmacies. This pathway aims to ensure continuity of pharmaceutical services for patients affected by the closures.

FDA Draft Guidance on Alternatives to Animal Testing in Drug Development

The FDA has issued draft guidance to assist drug developers in validating new approach methodologies (NAMs) as alternatives to animal testing in drug development. This guidance supports the FDA's roadmap to reduce animal testing and bring safe, effective drugs to market sooner.

FDA Early Alert: Surgical Stapler Issue Linked to Bleeding, Death

The FDA issued an Early Alert regarding a potentially high-risk issue with Intuitive Surgical's 8mm SureForm 30 Gray Reload surgical staplers. The issue has been linked to incomplete staple lines, causing bleeding and resulting in four serious injuries and one death. Affected customers are advised to immediately stop use and quarantine the product.

MHRA Modernises Medicine Information Delivery

The MHRA has launched a project to modernise how medicines product information is delivered to patients, aiming for greater accessibility and trust. This initiative includes research into the role of patient information leaflets.

DEA: Xylazine Involved in 6,096 Overdose Deaths in 2023

The DEA issued a public safety alert stating that xylazine was involved in 6,096 overdose deaths in 2023, making it the fourth most common drug in such fatalities. The alert indicates that all 50 states have reported the presence of xylazine in the illicit drug supply.

MHRA-NICE Joint Process for Faster Medicine Approvals

The MHRA and NICE have launched a new joint pathway and an improved Integrated Scientific Advice service to streamline medicine approval processes in England. This aims to bring new medicines to patients up to six months sooner by synchronizing licensing and value assessment decisions.

MHRA: Baxter Onkotrone Injection Defective Patient Information Leaflets

The MHRA has issued a Class 4 Medicines Defect Notification regarding Baxter Healthcare Corporation's Onkotrone Injection. Certain batches contain Patient Information Leaflets (PILs) with outdated contraception duration information. Healthcare professionals are advised to inform female patients of the updated requirement.

DEA Announces Multiple Drug Enforcement Actions and Arrests

The DEA has announced multiple drug enforcement actions and arrests across various field divisions, including significant seizures of illicit funds and convictions for drug trafficking and money laundering. These actions highlight ongoing efforts to combat transnational criminal organizations and dismantle drug distribution networks.

FDA Final Guidance on Topical Drug Product Characterization for ANDAs

The FDA has issued final guidance for industry on the physicochemical and structural characterization of topical drug products submitted in Abbreviated New Drug Applications (ANDAs). This guidance assists applicants in identifying generic topical products and supporting bioequivalence demonstrations. It finalizes the draft guidance issued in October 2022.

FDA Warning Letter to Prilla.com for Unapproved Nicotine Products

The FDA issued a warning letter to prilla.com/us on March 6, 2026, for marketing new nicotine pouch products without the required premarket authorization. The agency determined that products like VITO Watermelon 6mg and VITO Mango Fusion 6mg are adulterated and misbranded under the FD&C Act.

FDA Warning Letter to Trangs Group USA Incorporated

The FDA issued a warning letter to Trangs Group USA Incorporated for significant violations of the Foreign Supplier Verification Program (FSVP) regulation. The company failed to develop and maintain an FSVP for imported foods, including specific frozen bao products. The FDA may take further action if the violations are not addressed.

FDA Warning Letter to Patcos Cosmetics for Adulterated Drugs

The FDA issued a warning letter to Patcos Cosmetics Pvt. Ltd. for insanitary conditions and violations of Current Good Manufacturing Practice (CGMP) at their drug manufacturing facility. The letter details specific violations observed during an inspection and deems the company's response inadequate.

FDA Warning Letter to Flowchem Pharma Private Limited

The FDA issued a warning letter to Flowchem Pharma Private Limited following an inspection that revealed significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs). The letter details issues with equipment cleaning and maintenance, which could compromise API quality and safety.

FDA Warning Letter to OraLabs Inc. Regarding Drug Manufacturing

The FDA issued a warning letter to OraLabs Inc. for significant violations of Current Good Manufacturing Practice (CGMP) regulations. The company failed to conduct necessary laboratory testing for drug products, leading to adulterated drugs. The FDA requires a comprehensive remediation plan and testing of retain samples.

FDA Warning Letter to Citra100mg for Unapproved Opioid Sales

The FDA issued a warning letter to Citra100mg for unlawfully selling unapproved and misbranded opioid drugs, including tramadol, to U.S. consumers over the internet. The agency cited violations of the Federal Food, Drug, and Cosmetic Act and highlighted the public health risks associated with unapproved opioids.

Siemens RAPIDPoint 500 Blood Gas Systems Recall

Health Canada has issued a Type II recall for Siemens RAPIDPoint 500 Blood Gas Systems due to Measurement Cartridges potentially being exposed to temperatures outside specified storage conditions during transport. This may affect cartridge performance, and affected healthcare providers should contact the manufacturer.

Olympus Medical Cutting Forceps Recalled Due to Jaw Breakage Risk

Health Canada has issued a Type II recall for Olympus Medical PK/PKS/Everest Cutting Forceps due to a risk of jaw breakage during clinical use. The manufacturer identified inadequate supplier welding validation, and customers are requested to return affected products.

Philips Recalls Allura Xper/Azurion Systems for X-ray Imaging Issues

Health Canada issued a recall for Philips Allura Xper and Azurion X-ray imaging systems due to performance issues with the wired foot switch. The recall affects multiple models and advises healthcare providers to contact the manufacturer for additional information.

Health Canada Recalls Disinfectant Spray & Wipe Cleaner

Health Canada has issued a recall for specific lots of Coastwide CP15 Disinfectant Spray & Wipe Cleaner due to the active ingredient strength not meeting the labelled concentration. Retailers are instructed on the depth of the recall, and consumers are advised on actions to take.

Medical Device Recall: Incorrect Expiration Dates

Health Canada has issued a recall for several medical devices, including the Approach® CTO Micro Wire Guide and various catheter sets, due to incorrect expiration dates on the labelling. The manufacturer, Cook Incorporated, is providing information to healthcare professionals. This recall impacts multiple lot and model numbers.

Health Canada Recalls GEM PAKs for GEM Premier 5000 Due to Errors

Health Canada has issued a recall for GEM PAKs used with the GEM Premier 5000 due to an increased incidence of 'Process Control Solution Not Detected' errors. These errors can lead to GEM PAK ejection and require replacement, potentially delaying patient management.

Nivolumab for Urothelial Cancer Appraisal Terminated

NICE has terminated the appraisal of nivolumab for urothelial cancer because the company failed to submit evidence. The guidance will be reviewed if the company decides to make a submission in the future.

Ruxolitinib cream for non-segmental vitiligo in people 12+

NICE has published updated technology appraisal guidance (TA1140) on ruxolitinib cream for treating non-segmental vitiligo in individuals aged 12 and over. This guidance replaces previous recommendations and includes information on commercial arrangements for the drug.

ANSM Safety Recall: Autoimmunity IDS SS-A/Ro Reagent

The French ANSM has issued a safety recall (R2532493) for a specific lot of the Autoimmunity IDS SS-A/Ro reagent manufactured by Immunodiagnostic Systems (IDS). Laboratories using this reagent have been notified directly by the manufacturer.

Philips Respironics BiPAP A40 Pro Ventilator - Discontinuation and Safety Alert

Philips Respironics is discontinuing the BiPAP A40 Pro ventilator globally due to an internal oxygen sensor defect causing false alarms. The company offers patients options for continued care, including device replacement or partial reimbursement. Healthcare providers must inform affected patients of these options.

Curosurf 240 mg/3 ml Suspension Recall by Chiesi SAS

The French ANSM has announced a recall of a specific lot (Lot 1211845, Exp 07/2026) of Curosurf 240 mg/3 ml suspension for endotracheobronchial instillation. This action was initiated by the manufacturer, Chiesi SAS, as a precautionary measure due to a resolved deviation observed during environmental monitoring.

Philips Spectral CT Scanner Software Safety Alert

The French ANSM has issued a safety alert (R2607608) regarding Philips Spectral CT scanner systems with software version 5.1.X. Healthcare facilities using these devices have been notified of a security action initiated by Philips Medical Systems BV.

Leksell Vantage stereotactic system safety information

The French ANSM has issued a safety notice regarding the Leksell Vantage stereotactic system by Elekta Ltd. This action, registered under number R2607991, is based on a safety action implemented by the manufacturer. Affected healthcare facilities have been notified.

ANSM Drug & Device Safety Alert: Endoscopic Clip Device

The French ANSM has issued a safety information notice regarding a recall of specific lots of the Instinct Plus endoscopic clip device by Wilson-Cook Medical, Inc. This action follows a previous safety alert and is registered under ANSM reference R2606331.

ANSM Safety Information for Hemostasis Reagent STA NeoPTimal 5

The French ANSM has issued a safety information notice regarding the Hemostasis Reagent STA NeoPTimal 5, manufactured by Diagnostica Stago. Affected users have been notified directly by the company, and the action is registered under ANSM number R2607353.

FDA: Dialysis Tubing Sets Recalled Due to Dislodging, Updated Instructions

The FDA is alerting healthcare providers about a recall of Vantive dialysis tubing sets due to potential dislodging of the deaeration chamber. Updated instructions for use have been issued to mitigate risks, emphasizing monitoring the chamber during therapy. This is a correction and does not involve removing the devices from use or sale.

Integra LifeSciences Convenience Kit Needle Recall

The FDA is alerting the public about a recall initiated by Integra LifeSciences for certain Convenience Kit Needles, specifically the Codman Microsensor Basic Kits and Cerelink ICP Sensor Basic Kits. Affected customers and distributors are instructed to immediately remove these devices from service or distribution.

DEA Seizes Over Half a Million Vape Cartridges and Drugs in San Diego

The DEA announced a massive seizure in San Diego, confiscating over half a million vape cartridges and other illicit drugs. This action highlights the ongoing threat posed by illegal substances to public health and safety, with multiple law enforcement agencies collaborating in the operation.

DEA Seattle Fentanyl Enforcement and Awareness Initiative

The DEA's Seattle Division is launching a "Fentanyl-Free America" initiative in the Pacific Northwest, focusing on increased enforcement, education, and awareness. This initiative aims to combat the fentanyl crisis through collaborative efforts.

MHRA Field Safety Notices for Medical Devices

The MHRA has published a list of Field Safety Notices (FSNs) for medical devices issued between March 9-13, 2026. These notices are for informational purposes, and recipients are advised to act on any FSN received from a manufacturer.

MHRA NICE Integrated Scientific Advice Service Guidance

The MHRA and NICE have updated guidance on their Integrated Scientific Advice (ISA) service for medicine developers. The updates provide additional information on preparing for ISA meetings, including specific guidance on writing questions, creating briefing books, and understanding ISA reports and fees.

EMA CHMP Agenda: Hetlioz for Smith-Magenis Syndrome

The European Medicines Agency (EMA) has published the agenda for an extraordinary CHMP meeting on March 16, 2026. The agenda includes discussions on the re-examination procedure for Hetlioz (Tasimelteon) for Smith-Magenis Syndrome, involving oral explanations and variations to marketing authorisations.

COVID-19 Vaccines: Safety Profile Confirmed

The French National Agency for the Safety of Medicines and Health Products (ANSM) has confirmed the safety profile of COVID-19 vaccines. The agency stated that no new safety signals have been identified, reinforcing the established safety of these vaccines.

Product Recall: Mako Surgical Corp. MICS3 Fixation Device

The ANSM has announced a product recall for the Mako Surgical Corp. MICS3 fixation device, registered under recall number R2606434. The recall targets pharmacies and healthcare facilities, with two identified users having received direct communication from the manufacturer.

Polysilane UPSA gel oral recall notice

The ANSM has issued a recall notice for specific lots of Polysilane UPSA oral gel due to the potential presence of food-grade joint particles. The recall is a precautionary measure affecting the distribution chain, and the product will be unavailable until the issue is resolved.

Stryker Osteosynthesis Screws Recalled Due to Safety Concerns

The French ANSM has announced a recall of Stryker osteosynthesis screws (7.0 mm Darco headless screws, 16x60 mm) due to safety concerns. This action, registered under recall number R2606623, affects pharmacies and users who have received direct communication from Stryker Instruments.

Neonatal incubator safety alert: Lifetherm 2000

The ANSM has issued a safety alert regarding the Lifetherm 2000 neonatal incubator manufactured by Löwenstein Medical GmbH & Co. KG. The alert, registered under number R2607231, concerns a specific healthcare facility and includes a letter from the manufacturer detailing the safety action.

Impella AIC consoles with software <10.1 and Impella 5.5 first-gen safety alert

The ANSM has been informed of a safety action by Abiomed concerning Impella AIC consoles with software versions prior to 10.1, when used with first-generation Impella 5.5 ventricular assist devices. Healthcare providers using these devices have received specific instructions from Abiomed.

Pure Vitamins LLC Recalls Honey Products Due to Undeclared Sildenafil and Tadalafil

Pure Vitamins and Natural Supplements, LLC is voluntarily recalling honey products marketed as sexual enhancement due to undeclared sildenafil and tadalafil. These undeclared ingredients can interact with prescription medications and cause dangerous drops in blood pressure.

Instinct Plus Endoscopic Clipping Device Recalled Due to Malfunctions

Health Canada has issued a Type II recall for the Instinct® Plus Endoscopic Clipping Device manufactured by Wilson-Cook Medical, Inc. due to malfunctions where the clip may remain attached to the drive wire and cannot be opened. This recall affects products manufactured prior to corrective actions being implemented.

Arjo Tenor Mobile Lift Recall

Health Canada has issued a Type II recall for the Arjo Tenor Mobile Lift due to a defect in the brake component of the actuator. The defect can cause a loss of self-locking and uncontrolled descent, posing a safety risk. Affected units must be removed from use immediately.

Monoject Syringe Recall - Incorrect Insulin Labeling

Health Canada has issued a recall for Monoject 1mL Luer Lock Syringes due to incorrect insulin labeling. The outer packaging indicates a tuberculin syringe, but the syringes inside are U-100 insulin syringes. Healthcare providers are advised to contact the manufacturer for more information.

SOLTIVE Laser System Recall

Health Canada has issued a Type II recall for the SOLTIVE Premium SuperPulsed Laser System due to a defect in the 24V power supply causing sudden power loss. Affected healthcare providers should contact the manufacturer for service coordination.

FDA Approves Tec-Dara for Relapsed Multiple Myeloma

The FDA has approved Tec-Dara (teclistamab and daratumumab hyaluronidase-fihj) for relapsed or refractory multiple myeloma. This approval was granted under the Commissioner's National Priority Voucher (CNPV) pilot program, marking a significant acceleration in the review process.