Class 4 Medicines Defect Notification: Cadila Pharmaceuticals Limited, Mirtazapine 30mg Tablets, EL(26)A/28
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
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 | 28b | 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.
Advice for 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
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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