PV Bulletin

Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Drug safety and regulatory intelligence for QPPV, Signal, Labeling, PV Ops, and Device Vigilance — daily briefings with operational next steps.

Latest intelligence

publicFDA · USA · Updated Jun 4, 2026

FDA Safety Labeling Change Order for ADZYNMA

Urgency: High

Review the specific labeling changes required by the FDA order and update internal safety documents and signal evaluation for ADZYNMA accordingly.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Safety Labeling Change Order
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publicTGA · Australia · Updated Jun 4, 2026

Unapproved ibutamoren capsules (MK-677) found to contain undisclosed anabolic steroid

Urgency: High

Consumers must stop taking the product immediately and return remaining capsules to a pharmacy for safe disposal.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Safety Alert
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publicHealth Canada · Canada · Updated Jun 3, 2026

Dexcom G7 Sensor Lot Recall – Unauthorized Distribution of Non-Conforming Lots in Canada

Urgency: High

Identify and quarantine products from lots 1725204004 and 1725069002; contact patients who received sensors from these lots; report adverse events if any.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Medical Device Recall
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publicTGA · Australia · Updated Jun 3, 2026

Nature's Own Glucosamine Sulfate with Chondroitin and Nature's Own Magnesium Glycinate 1150mg Recall by Sanofi Consumer Healthcare

Urgency: High

Return recalled products to place of purchase for refund or contact Customer Care for return arrangements.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Recall
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publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 2, 2026

MHRA Class 2 Recall: ChloraPrep 2% applicators (potential sterility breach)

Urgency: High

Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Class 2 Medicines Recall
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publicHealth Canada · Canada · Updated Jun 1, 2026

Omnipod Insulin Management System Recall in Canada

Urgency: High

Identify affected lots and implement recall procedures as per Health Canada guidelines.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Health product recall
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publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated May 29, 2026

MHRA Largest Seizure of Unlicensed Weight Loss Medicines

Urgency: High

Review adverse event reports for potential links to counterfeit weight loss medicines; check product supply chain for unlicensed sources.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Enforcement Action / Public Safety Alert
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publicFDA · United States · Updated May 29, 2026

FDA Public Notification: Tawon Liar Contains Hidden Drug Ingredients

Urgency: High

Review product inventory for Tawon Liar; report any adverse events to FDA MedWatch; consider adding product to signal monitoring list; ensure labeling compliance checks for similar products.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Public Notification
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