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

Primary tabs

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.

DMRC Number: DMRC - 39523288

Company name:Cadila Pharmaceuticals Limited, Dholka, India

Product description: Mirtazapine 30mg Tablets (Crescent Pharma Limited livery)

PL: 45841/0023

Active ingredient: mirtazapine

SNOMED code: 38410211000001105

Details of the affected batch:

Batch No.Expiry DatePack SizeFirst Distributed
ET570E501208/202828b09/04/2026

Background information: 

Cadila Pharmaceuticals Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of the above batch of Mirtazapine 30mg Film-Coated Tablets distributed in Crescent Pharma Limited livery. When scanned, the EAN barcode identifies the product as Bicalutamide 50 mg Tablets. The quality of the tablets is not impacted by the labelling defect.

Advice to Healthcare Professionals: 

Do not to use this batch of medicine in robotic or automated dispensing or stock control systems. Healthcare professionals and recipients of this notification are advised not to use this batch of medicine in robotic or automated dispensing or stock control systems and to carry out manual dispensing and stock control, as appropriate.

Advice to Patients: 

No action is needed from patients, continue to take medication from this batch as prescribed by your healthcare professional. The issue is related to the wrong barcode on the cartons of the listed batch of Mirtazapine 30mg Tablets and will be controlled by the healthcare professionals prescribing/dispensing the medication. The quality of the tablets is not affected.

Patients should continue to take medicines from this batch as prescribed by your healthcare professional.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information: 

For medical information enquiries please contact pharmacovigilance-eu@cadilapharma.com or telephone +44 1217901596

For stock control enquiries please contact info@crescentpharma.com or telephone 01256 772730

To access the full recall/alert: 

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