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 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.
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 [email protected] or telephone 01582 809833.
For stock control enquiries please email [email protected] or telephone 01582 809833.
Recipients of this Medicines Recall 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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