Class 4

Class 4 Medicines Defect Notification: Fexofenadine Hydrochloride 120mg film-coated tablets, Chanelle Medical Unlimited Company, EL(25)A/41

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Cathy

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Chanelle Medical Unlimited Company has informed the MHRA of an error with the European Article Number (EAN) / Global Trade Item Number (GTIN) barcode on certain batches of Fexofenadine Hydrochloride 120mg film-coated tablets, distributed by Healthcare Pharma Limited.

DMRC Number: DMRC - 36081293

Company name:Chanelle Medical Unlimited Company

Product description: Fexofenadine Hydrochloride 120mg film-coated tablets- PL: 13931/0039, SNOMED code: 14161911000001109, GTIN: 5099299199583

Details of the affected batches:

Batch No.Expiry DatePack SizeFirst Distributed
HM11123A28/02/202630s20/09/2023
HM1052328/02/202630s29/08/2024
HM1062328/02/202630s19/09/2024
HM10723A28/02/202630s19/09/2024
HM1082328/02/202630s31/10/2024
HM1092328/02/202630s15/01/2025
HM1102328/02/202630s31/01/2025
HM1122328/02/202630s11/02/2025
HM1132328/02/202630s17/02/2025
HM1142328/02/202630s25/02/2025
HM1162328/02/202630s25/02/2025
HM11523A31/03/202630s25/02/2025
HM1172331/03/202630s11/03/2025
HM1182331/03/202630s31/03/2025
HM1192331/03/202630s02/04/2025
HM1202331/03/202630s02/04/2025
HM1212331/03/202630s02/04/2025
HM1222331/03/202630s02/04/2025
HM12323A31/03/202630s02/04/2025
HM1242331/03/202630s08/04/2025
HM1252331/03/202630s24/04/2025
HM1262331/03/202630s30/04/2025
HM1272330/04/202630s16/04/2025
HM1282330/04/202630s20/05/2025
HM1292330/04/202630s11/06/2025
HM1302330/04/202630s13/06/2025

Background information: 

Chanelle Medical Unlimited Company has informed the MHRA of an error with the European Article Number (EAN) / Global Trade Item Number (GTIN) barcode on the cartons of the above batch of Fexofenadine Hydrochloride 120mg film-coated tablets, distributed by Healthcare Pharma Limited. When scanned, the EAN/GTIN barcode identifies the product as Naratriptan 2.5mg Tablets.

The other product details on the carton, including the name, strength and pharmaceutical form of the medicine are correct. The quality of the medicine is not impacted by the labelling defect.

Advice to Healthcare Professionals:

Healthcare professionals are advised to use caution and consider extra safeguards for these batches in robotic or automated dispensing system or stocking systems and should carry out manual dispensing and stocking, as appropriate.

The product quality of the Fexofenadine Hydrochloride 120mg film-coated tablets is not impacted by this issue, therefore the affected batches are not being recalled.

All remaining stock of Naratriptan 2.5mg Tablets which has not been distributed from UK wholesaler will be placed on hold until April 2026 (Last expiry of impacted Fexofenadine stock) to provide further mitigation that the wrong product may be selected.

Advice to Patients: 

No action is needed from patients, continue to take medication from these batches as prescribed by your healthcare professional. The issue is related to the wrong barcode on the cartons of the listed batch of Fexofenadine Hydrochloride 120mg film-coated tablets and will be controlled by the healthcare professionals prescribing/dispensing the medication. The quality of the medication is not affected. 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.

Company contacts for further information: 

For all medical information enquiries and information on this product, please contact Medical Information Department chanelle@medinformation.co.uk or telephone +44 808 304 2429 (Toll free-UK). 

Foe stock control enquiries please email David Hammond david.hammond@healthcarepharma.co.uk

To access the full recall/alert: Class 4 Medicines Defect Notification: Fexofenadine Hydrochloride 120mg film-coated tablets, Chanelle Medical Unlimited Company, EL(25)A/41