A class 4 defect notification has been issued for one batch of the antidepressant medicine, mirtazapine 30mg film-coated tablets, due to a barcode error on the cartons.
The warning was issued after the drug’s manufacturer, Cadila Pharmaceuticals Limited, informed the Medicines and Healthcare products Regulatory Agency (MHRA) of an error with the European article number (EAN) barcode.
The affected batch of mirtazapine was distributed in Crescent Pharma Limited livery, and, when scanned, the EAN barcode incorrectly identifies the product as bicalutamide 50 mg tablets.
According to the defect notification, the quality of the tablets is not impacted by the labelling defect.
Affected lot batch number:
- ET570E5012 – expiring: 08/2028 – pack size: 28b – first distributed: 09/04/2026
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.
Mirtazapine is an antidepressant medicine. It's used to treat depression and sometimes obsessive compulsive disorder and anxiety.
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.
This defect warning linked to Crescent Pharma Limited follows a series of recalls of the company’s hypertension medicine, ramipril, for other packaging errors.
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