Pharma & Life Sciences

Integra LifeSciences Recalls MediHoney and CVS Wound Dressings

The FDA announced a recall initiated by Integra LifeSciences for certain MediHoney and CVS Wound Gel products due to packaging failures that could lead to infection or delayed care. The recall involves removing affected products from service and distribution. Integra LifeSciences has reported 11 serious injuries related to MediHoney and three related to CVS Wound Gel.

UK Agencies Support In-Orbit Pharmaceutical Manufacturing

The UK Space Agency, MHRA, RIO, and CAA have issued a joint statement outlining their support for companies involved in in-orbit pharmaceutical manufacturing. This initiative aims to foster a supportive regulatory environment through guidance and collaborative studies, reinforcing the UK's commitment to space-enabled manufacturing.

MHRA Class 2 Recall: Crescent Pharma Ramipril 5mg Capsules

The MHRA has issued a Class 2 medicines recall for one batch of Crescent Pharma Limited's Ramipril 5mg Capsules due to a manufacturing error where incorrect blister strips were found in the packaging. Healthcare professionals are instructed to stop supplying the affected batch immediately and contact patients who received the product.

Ramipril Recall Due to Packaging Error

The MHRA has issued a precautionary recall for one batch of Ramipril 5 mg Capsules (Batch Number GR164099) due to a packaging error that may have resulted in Amlodipine 5 mg Tablets being included in the cartons. Pharmacy and healthcare professionals are advised to return remaining stock to suppliers.

Honda and Acura SUV Recall - Instrument Cluster Display Issue

Transport Canada has issued a recall for 2024 Honda Prologue and Acura ZDX SUVs due to a software issue that can cause the instrument cluster and infotainment display to go blank while driving. This poses a safety risk by preventing drivers from seeing critical information and the rearview camera.

International Motors Bus Recall - Brake Line Issue

Transport Canada has issued a recall for certain 2025-2026 IC BUS CE COMMERCIAL BUS models manufactured by International Motors due to a potential brake line issue. The recall addresses the risk of reduced braking performance, increasing the risk of a crash.

International Motors School Bus Brake Lines Recalled

Transport Canada has issued a recall for International Motors school buses due to a potential issue with brake lines not being secured correctly. This could lead to brake fluid leaks and reduced braking capability, increasing the risk of a crash. Owners will be notified to have the brake lines inspected and replaced.

BMW Motorcycle Recall - Turn Signals May Not Work

Transport Canada has issued a recall for BMW motorcycles due to a potential defect in the left combination switch, which may prevent turn signals from functioning. The issue poses a safety risk, as non-functional turn signals could increase the risk of a crash. Affected motorcycles have not yet been delivered to customers.

Draft Guidance: Responding to FDA Form 483 Observations for Drug Manufacturers

The FDA has issued draft guidance for drug manufacturers on how to respond to observations noted on FDA Form 483 following CGMP inspections. This guidance is intended to assist domestic and foreign manufacturers in assessing conformity with CGMP requirements.

Shimadzu FDR Visionary Suite Health Product Recall

Health Canada has issued a Type II recall for Shimadzu Corporation's FDR Visionary Suite medical device due to a potential safety issue with the X-ray high voltage generator. The issue could lead to overheating and smoke. Healthcare providers are advised to contact the manufacturer for more information.