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Instinct Plus Endoscopic Clipping Device Recall

Health Canada has issued a Type II recall for the Instinct® Plus Endoscopic Clipping Device manufactured by Wilson-Cook Medical, Inc. due to 486 reported malfunctions where the clip fails to open. This recall is to withdraw products manufactured prior to corrective actions being implemented.

SOLTIVE Premium SuperPulsed Laser System Recall

Health Canada has issued a Type II recall for the SOLTIVE Premium SuperPulsed Laser System manufactured by Gyrus Acmi, Inc. The recall is due to a defect in the 24V power supply causing sudden power loss or failure to power on. Affected customers will be contacted by Olympus representatives to schedule service.

Digimerck Tablets Quality Defect: Degradation Products May Exceed Limit

The German Federal Institute for Drugs and Medical Devices (BfArM) issued a Direct Healthcare Professional Communication regarding Digimerck 0.07 mg tablets. A quality defect has been identified where degradation products may slightly exceed the specification limit by the end of the product's shelf life. Distribution was discontinued in 2022.

Kisqali Tablets: Updated Storage Conditions and Shelf Life

Novartis Pharma GmbH has updated the storage conditions and shelf life for Kisqali 200 mg film-coated tablets. The medicine no longer requires refrigeration and now has an authorized shelf life of 2 years. This information letter was issued by the BfArM.

Melphalan AqVida: Risk of Overdose Due to Higher Concentration

The German Federal Institute for Drugs and Medical Devices (BfArM) issued a communication regarding Melphalan AqVida RTD 90 mg/ml, a new formulation with an 18-fold higher concentration than existing melphalan products. This increased concentration poses a potential risk of overdose for patients.

Arixtra Quality Defect: Needle Discoloration and Iron Particle

The German Federal Institute for Drugs and Medical Devices (BfArM) issued a notice regarding a quality defect in Arixtra pre-filled syringes. Reports indicate brown discoloration and needle blockage due to oxidized iron particles, posing a risk to patients. Healthcare professionals are instructed not to dispense or administer affected products.

Tegretal Suspension Use Restricted in Newborns

The German Federal Institute for Drugs and Medical Devices (BfArM) has issued a direct healthcare professional communication restricting the use of Tegretal Suspension (carbamazepine) in newborns due to high propylene glycol content. This restriction is to prevent serious side effects in infants.

PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in their October 2025 meeting. These recommendations are directly actionable by marketing authorisation holders (MAHs) for updates to product information.

PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed between September 29 and October 2, 2025. These recommendations are directly actionable by marketing authorisation holders (MAHs) for both Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs).

PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in February 2026. These recommendations require marketing authorisation holders (MAHs) to provide supplementary information or take regulatory action, such as updating product information.