Quality & compliance

Eugia US LLC (f/k/a Auro Medics Pharma LLC) Issues Voluntary Nationwide Recall of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial) Due to Presence of Particulate Matter

Dutch inspectorate flags sterile packaging failure on BS-MTI Tumorstent Innoflex Mono ureteral stent

IGJ reports that the stent's sterile packaging failed a microbial barrier test after five years of real-time aging, leaving its claimed five-year shelf life unsupported.

Health Canada flags recall of two Nova StatStrip ketone test strip lots over QC failures

Nova Biomedical's StatStrip Ketone Test Strips, model 66841, are being recalled in Canada after affected lots showed more quality control failures during use, though patient blood results are unaffected.

Siemens Healthineers recalls MAGNETOM Flow.Ace software over cardiac flow quantification issue, Health Canada reports

Health Canada has posted a Type II recall covering a syngo.via MR Flow Quantification issue when Beat Sensor triggering is used for retrospectively gated 2D cardiac flow scans on the MRI system.

Olympus recalls further reusable HF-cable models in Canada after earlier WA00014A recall

Health Canada has published a Type II recall covering reusable monopolar and bipolar HF-cables from Olympus Winter & Ibe, with a reminder on service-life instructions.

BfArM publishes Funke Medical urgent field safety notice for mattress extensions

Germany's BfArM has listed a manufacturer advisory from Funke Medical GmbH on its Matratzenverlängerung, but the public entry gives no detail on the problem or the corrective action.

Florida clinic CEO and VA employee sentenced over healthcare kickbacks steering veterans to clinic

Heriberto Rivera received 13 months and Laurent Cassagnol 6 months for a bribery conspiracy that sent VA Community Care patients to an Orlando clinic.

ANSM fines Biocon Biologics France over Fulphila stock-shortage reporting, decision shows

The French regulator's 23 October 2026 decision cites rules on shortage notification for medicines of major therapeutic interest, following a risk declaration and an inspection in 2025.

SÚKL circulates information letter on Respreeza vial closure defect

Czech regulator SÚKL has published a marketing authorisation holder's letter to operators on a vial closure defect affecting CSL Behring's Respreeza 1000 mg.

Denmark reports November supply problems for MSD's CAPVAXIVE pneumococcal vaccine, citing higher demand

The Danish Medicines Agency says pre-filled syringes of CAPVAXIVE from MSD Danmark are affected, with disruption expected from early to late November 2026 due to increased sales.

Denmark flags supply problems for Amoxival Vet. 200 mg amoxicillin tablets from Ceva

DKMA says production problems at Ceva Animal Health A/S are disrupting supply of the 10-tablet pack, with availability expected to be affected from early November to early December 2026.

Denmark flags amoxicillin vet tablet shortage from Ceva Animal Health until early 2027

The Danish Medicines Agency reports production problems affecting Amoxival Vet. 200 mg tablets (20-pack), with supply expected to be disrupted from early November 2026 to early January 2027.

Denmark flags supply problems for Ceva's Amoxival Vet. 400 mg amoxicillin tablets

The Danish Medicines Agency expects disruption to the veterinary antibiotic from early November to early December 2026, citing production problems at Ceva Animal Health A/S.

MHRA orders Class 3 recall of Aspire Pharma tropicamide eye drops over wrong expiry date

Three batches of Tropicamide 1% single-dose eye drops carry an expiry date of April 2027, but the correct date is 31 October 2026, the MHRA says.

MHRA: Sandoz co-amoxiclav suspension SmPC dosing table error could double weight-based dose

The MHRA has issued a Class 4 defect notification for Sandoz's 250/62.5 mg/5 mL co-amoxiclav oral suspension after its SmPC dosing table was found to be wrong, with all batches affected.

Denmark flags Avipro IBD V217 poultry vaccine shortage linked to higher demand

The Danish Medicines Agency says Elanco's live infectious bursal disease vaccine for drinking water is in short supply, with disruption expected from mid-September to mid-December 2026.

Production problems disrupt Danish supply of Elanco's AviPro IBD LC-75 veterinary vaccine

The Danish Medicines Agency says supply of Elanco's live attenuated infectious bursal disease vaccine is expected to be disrupted from late September to mid-December 2026.

MHRA flags Sandoz co-amoxiclav suspension SmPC dosing table error implying roughly double dose

A Class 4 defect notice says the weight-based dosing table in Sandoz's co-amoxiclav 250/62.5 mg/5 ml SmPC is wrong, and the document has been withdrawn from MHRA and eMC websites.

BfArM publishes Brainlab urgent field safety notice for Navigation Software Cranial EM

Germany's BfArM has posted a Brainlab AG field safety notice for its cranial electromagnetic navigation software, but the listing does not describe the issue or required actions.

BfArM publishes Liko AB urgent field safety notice for Likorall Overhead Lift

Germany's federal medical device authority has listed a manufacturer safety notice for a patient-lifting device, but the hazard and affected units are detailed only in an attached document.

FDA lists Class II recall of Handtastic Foamy Mango antiseptic foam soap over CGMP deviations

Abc Compounding Co., Inc.'s hand and body wash is subject to recall D-0095-2027, which is ongoing and covers nationwide US distribution, according to the FDA enforcement report.

FDA lists Class II recall of Brandywine's theophylline extended-release tablets over stability testing lapse

The recall, numbered D-0111-2027, stems from an interruption in an ongoing stability programme at a third-party laboratory and covers nationwide US distribution.

FDA lists Class II recall of Lynx from ABC Compounding over CGMP deviations

The US regulator's enforcement report records an ongoing, nationwide Class II drug recall of Lynx, attributed to current good manufacturing practice deviations at ABC Compounding Co., Inc.

FDA lists Class II recall of Delta Foremost Sani-Foam Mango over CGMP deviations

An FDA enforcement report entry records an ongoing Class II recall of Delta Foremost Sani-Foam Mango, made by Abc Compounding Co., Inc., and distributed across the US.

FDA classifies Abc Compounding antiseptic hand and body wash recall as Class II over CGMP deviations

The nationwide recall of Aero Foamy Mango Aloe Vera Antiseptic Hand & Body Wash, logged as D-0087-2027, remains ongoing in the FDA's enforcement report.

FDA lists Class II recall of Glenmark abiraterone acetate 500 mg tablets over labelling issue

Glenmark Pharmaceuticals Inc., USA is recalling Abiraterone Acetate Tablets USP 500 mg nationwide; the FDA enforcement report classifies the action as Class II and ongoing.

FDA lists Class II recall of Eagle Pharma Outsourcing oxytocin over lack of sterility assurance

The recall, numbered D-0106-2027 and still ongoing, covers oxytocin distributed nationwide within the United States, according to the FDA enforcement report.

FDA lists Class II recall of MSN atorvastatin tablets over foreign tablets or capsules

An FDA enforcement report entry classifies a nationwide US recall of atorvastatin calcium tablets from MSN Laboratories' Unit-II as Class II, citing the presence of foreign tablets or capsules.

FDA lists Class II recall of Abc Compounding's FM-24 Foaming antiseptic hand and body wash

The recall, classified for CGMP deviations, is ongoing and covers product distributed across the US, according to the FDA enforcement report.

FDA lists Class II recall of phenylephrine infusion over sterility assurance concerns

Eagle Pharma Outsourcing LLC's phenylephrine HCl infusion is subject to an ongoing nationwide US recall, classified for lack of assurance of sterility.