MHRA Class 4 Medicines Notification: Trazodone hydrochloride 50mg/5ml oral solution (Cygnus Pharma Ltd)

Class 4 Medicines Defect Information: Trazodone hydrochloride 50mg/5ml oral solution (Cygnus Pharma Ltd)

Drug alert number: EL (24)A/16

Date issued: 20 May 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Trazodone hydrochloride 50mg/5ml oral solution (Cygnus Pharma Ltd)

Company name: Cygnus Pharma Ltd

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

SNOMED Code: N/A

Batch Number Expiry date Pack size First distributed
AS240145A 03/2027 120 ml May 2024
AS240146A 03/2027 120 ml May 2024

Active Pharmaceutical Ingredient: Trazodone hydrochloride

Brief description of the 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 for 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.

View full alert here.

Advice for 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.

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.

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