The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a defect notification for several batches of fexofenadine tablets, which have an error in their European Article Number (EAN) / Global Trade Item Number (GTIN) barcode.
The affected product is 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 issue was reported to the MHRA by manufacturer Chanelle Medical Unlimited Company.
The quality of the product is not affected by this issue and therefore, the affected batches are not being recalled, the MHRA said.
The other product details on the carton, including the name, strength and pharmaceutical form of the medicine are correct.
Fexofenadine hydrochloride is an antihistamine, used to relieve symptoms of hay fever and hives of the skin.
Healthcare professionals have been advised to use caution and consider additional safeguards for these batches in robotic or automated dispensing system or stocking systems.
Manual stocking and dispensing should be carried out as appropriate, the MHRA said.
All remaining stock of Naratriptan 2.5mg tablets which has not been distributed from UK wholesalers will be placed on hold until April 2026 – the last expiration date of impacted Fexofenadine stock – to mitigate further risk of the wrong product being selected.
No action is needed from patients. The MHRA has instructed them to continue taking medication from these batches as prescribed.
Patients who experience adverse reactions should report them via the MHRA Yellow Card scheme.
A full list of the affected lot batch numbers can be found on the government website.
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