PV Bulletin

Withdrawal of FastPen 40mg Product by AZRL LTD

The ANSM decreed the withdrawal of the FastPen 40mg product, identified as containing a GLP-1 agonist, due to safety concerns.

Primary source: PUBLIÉ LE 19/11/2025 - MIS À JOUR LE 31/08/2026 L’ANSM prend des mesures de police sanitaire à l’encontre des sites inte

Translated From French

PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.

PV Impact Brief

Urgency: HighConfidence: high

What changed

The product 'FastPen 40mg' has been officially withdrawn from the market, necessitating an immediate recall by AZRL LTD.

Why it matters

This regulatory action highlights serious safety concerns regarding the medication, mandating compliance to protect public health.

Action needed

AZRL LTD must proceed with the recall of FastPen 40mg from all locations and suspend marketing activities until compliance is verified.

Relevant for
Regulatory Intelligence LeadMedical Safety Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Aug 31, 2026

Full briefing

Practical implication

AZRL LTD must proceed with the recall of FastPen 40mg from all locations and suspend marketing activities until compliance is verified.

The French National Agency for the Safety of Medicines and Health Products (ANSM) announced on August 14, 2026, the withdrawal of FastPen 40mg by AZRL LTD, due to safety issues associated with its use as a GLP-1 agonist. The decision includes an immediate recall of the product and a suspension of its marketing until compliance with regulations is achieved.

What changed: The product 'FastPen 40mg' has been officially withdrawn from the market, necessitating an immediate recall by AZRL LTD.

Why it matters: This regulatory action highlights serious safety concerns regarding the medication, mandating compliance to protect public health.

Practical implication: AZRL LTD must proceed with the recall of FastPen 40mg from all locations and suspend marketing activities until compliance is verified.

View original source

  • Source: ANSM (France) - News feed
  • Published at source: 2026-08-31T00:00:00.000Z
  • Discovered by monitor: 2026-08-31T21:32:58.820Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signal#Safety Signals#Source-ingestion#Regulator-monitor#Translated From French#France#Ansm.sante.fr

Related updates for your role

publicFDA · USA · Updated Aug 31, 2026

International Collaboration to Advance New Testing Methods That Reduce Reliance on Horseshoe Crab Blood

Urgency: High

Regulatory compliance processes may need updates to incorporate the new recombinant endotoxins testing method and guidelines established under the ICMRA framework.

Inspection ReadinessCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, PV Quality Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Aug 31, 2026Translated From French

ANSM (France) - Safety information feed: Ventilateur d'anesthésie – Systèmes d’anesthésie Aisys et AisysCS2 – GE Healthcare / Datex-Ohmeda sur le site de l'Agence nationale de sécurité du médicamentet des produits de santé Information de sé

Urgency: High

Healthcare facilities must complete preoperative checks, manage emergency O2 flow during usage, and return the response form to GE Healthcare within a maximum of 30 days.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Aug 31, 2026Translated From French

Beckman Coulter Iris iQ200 and DxU 840m/850m Analyzers Safety Notification

Urgency: High

All users of the affected analyzers are required to reply to the notification letter within 10 days and implement increased monitoring of device performance to prevent liquid leaks.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Aug 31, 2026Translated From French

ANSM (France) - Safety information feed: Mycologie – Réactif Yeastone Broth, 11ML – Thermo Fisher Scientific sur le site de l'Agence nationale de sécurité du médicamentet des produits de santé Information de sécurité - Mycologie – Réactif Yeasto

Urgency: High

Laboratories must immediately quarantine and return the affected product, and communicate with patients to manage their follow-up testing appropriately.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward