MHRA Class 4 Medicines Defect Notification: Mirtazapine 30mg Tablets (Cadila Pharmaceuticals) (Crescent Pharma Limited livery)

MHRA Class 4 Medicines Defect Notification: Mirtazapine 30mg Tablets (Cadila Pharmaceuticals)

Drug alert number: EL(26)A/28

Date issued: 08 June 2026

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 reference number: DMRC- 39523288

Marketing Authorisation Holder: Cadila Pharmaceuticals Limited, Dholka, India

Medicine Details

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

PL: 45841/0023

Active ingredient: mirtazapine

SNOMED code: 38410211000001105

GTIN: 05017123712135

 

Affected Lot Batch Numbers

Batch No. Expiry Date Pack Size First Distributed
ET570E5012 08/2028 28 09/04/2026

Background

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 for 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.

View the full alert here.

Advice for Healthcare Professionals to Provide 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.

Additional 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

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