PV Bulletin

Class 4 Defect Notification: Cadila Mirtazapine 30mg Tablets (EL(26)A/28)

Quality defect notification for Mirtazapine 30mg Tablets by Cadila Pharmaceuticals Limited; healthcare professionals to check affected batches.

Primary source: Medicines and Healthcare products Regulatory Agency (MHRA)

PV Impact Brief

Urgency: HighConfidence: high

What changed

MHRA published a Class 4 defect notification for Mirtazapine 30mg Tablets (Cadila Pharmaceuticals).

Why it matters

Product quality defect may affect patient safety; requires batch checking and potential product recall actions.

Action needed

Check for affected batches of Mirtazapine 30mg Tablets as described in EL(26)A/28 and implement any necessary quarantining or recall steps.

Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Owner

Regulatory Intelligence Lead

Review cadence

immediate

Regulatory action details

Action type
Medicines Defect Notification (Class 4)
Publication date
2026-06-08
Safety issue
Quality defect notification for Mirtazapine 30mg Tablets manufactured by Cadila Pharmaceuticals Limited.

Affected products

  • Mirtazapine 30mg Tablets
    Cadila Pharmaceuticals Limited

PV internal implications

Healthcare professionals should check for the affected batches and note the defect as described in EL(26)A/28.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 8, 2026

Full briefing

Practical implication

Check for affected batches of Mirtazapine 30mg Tablets as described in EL(26)A/28 and implement any necessary quarantining or recall steps.

MHRA issued a Class 4 Medicines Defect Notification for Mirtazapine 30mg Tablets (Cadila Pharmaceuticals Limited) on 8 June 2026. Healthcare professionals should identify affected batches and note the defect per EL(26)A/28.

What changed: MHRA published a Class 4 defect notification for Mirtazapine 30mg Tablets (Cadila Pharmaceuticals).

Why it matters: Product quality defect may affect patient safety; requires batch checking and potential product recall actions.

Practical implication: Check for affected batches of Mirtazapine 30mg Tablets as described in EL(26)A/28 and implement any necessary quarantining or recall steps.

View original source

Published from the Firecrawl agent regulatory extraction pipeline.

#Safety Signals#firecrawl-agent#regulatory-extraction#Other#Medicines and Healthcare products Regulatory Agency (MHRA)#Medicines Defect Notification (Class 4)

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