MHRAsafety guidance72% confidence
Class 4 Medicines Defect Notification: Cadila Pharmaceuticals Limited, Mirtazapine 30mg Tablets, EL(26)A/28
Source: MHRA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Orbit Pharma Limited.
Regulatory Analysis
Cadila Pharmaceuticals Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of Mirtazapine 30mg Film-Coated Tablets distributed in Crescent Pharma Limited livery.
Supporting Context
- Therapeutic area
- Neurology · Antiemetic
- Sub-indication
- General
Related signal: Orbit Pharma recalls Cyclizine Lactate due to GMP deficiencies