Class 4 Medicines Defect Information: Cygnus Pharma Ltd, Trazodone Hydrochloride 50mg/5ml Oral Solution, EL (24)A/16

Cygnus Pharma Ltd. have informed MHRA that the European Article Number (EAN) barcode printed on various packs of Trazodone Hydrochloride 50mg/5ml Oral Solution, is defective and returns the incorrect information.

MDR Number: MDR 260-04/24

Company name: Cygnus Pharma Ltd.

Product description: Trazodone Hydrochloride 50mg/5ml Oral Solution, PL 49255/0004

Details of the affected batches: 

Brief description of problem: 

Cygnus Pharma Ltd. have informed MHRA that the European Article Number (EAN) barcode printed on the packs is defective and returns the incorrect information. When scanned the returned information has not been assigned to any medicinal product. The printed barcode will not be used in the future for any product.

The 2D barcode and Global Trade Item Number (GTIN) which appears on the packs returns the correct information when scanned.

Advice to Healthcare Professionals:

The product quality and safety is not affected by this issue. The 2D barcode contains the correct information. Do not use the product with any automated prescribing or dispensing systems that use the EAN barcode.

The notification is intended to make wholesalers/retailers/pharmacies aware of the barcode discrepancy for the batches specified in the tablet and to confirm that the product quality and safety has not impacted by this discrepancy.

Advice to Patients:

The product quality and safety are not affected by this issue. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients who experience adverse reactions or have any questions about the 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 email info@cygnuspharma.co.uk or telephone 01582 809833.

For stock control enquiries please email info@cygnuspharma.co.uk or telephone 01582 809833.

To access the full recall: Class 4 Medicines Defect Information: Cygnus Pharma Ltd, Trazodone Hydrochloride 50mg/5ml Oral Solution, EL (24)A/16