Class 4 Medicines Defect Notification: Fexofenadine Hydrochloride 120mg film-coated tablets, Chanelle Medical Unlimited Company, EL(25)A/41
Source: gov.uk (2025-08-21)

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 reference number

DMRC - 36081293

Marketing Authorisation Holder

Chanelle Medical Unlimited Company

Medicine Details

Fexofenadine Hydrochloride 120mg film-coated tablets

Licence: PL: 13931/0039

Active ingredient: Fexofenadine Hydrochloride

SNOMED code: 14161911000001109

GTIN: 5099299199583

Affected Lot Batch Numbers

Background

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 for 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 for 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. (https://yellowcard.mhra.gov.uk/)

Additional information:

For all medical information enquiries and information on this product, please contact Medical Information Department xxx@xxx.xx (mailto:xxx@xxx.xx) or telephone xx-xxxx-xxxx (Toll free-UK). For stock control enquiries please email David Hammond: xxx@xxx.xx. (mailto:xxx@xxx.xx.) Recipients of this Medicines Recall should bring

Recipients of this Medicines Notification 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 Centre10 South ColonnadeCanary WharfLondonE14 4PU

Telephone xx-xxxx-xxxx

xxx@xxx.xx (mailto:xxx@xxx.xx)

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Class 4 Medicines Defect Notification: Fexofenadine Hydrochloride 120mg film-coated tablets, Chanelle Medical Unlimited Company, EL(25)A/41 (https://assets.publishing.service.gov.uk/media/68a5da109dc94e840696a3e6/EL_25_A41_Final.pdf)