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Medicines defect noticeMHRA

Fexofenadine Hydrochloride 120mg film-coated tablets defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

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.

Check your product

Only products that match these details are covered. Have your pack in front of you.

48 identifiers listed for this notice.

  • Fexofenadine Hydrochloride 120mg film-coated tablets, Chanelle Medical Unlimited Company 30’s

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • HM11123A
    • HM10523
    • HM10623
    • HM10723A
    • HM10823
    • HM10923
    • HM11023
    • HM11223
    • HM11323
    • HM11423
    • HM11623
    • HM11523A
    • HM11723
    • HM11823
    • HM11923
    • HM12023
    • HM12123
    • HM12223
    • HM12323A
    • HM12423
    • HM12523
    • HM12623
    • HM12723
    • HM12823
    • HM12923
    • HM13023
    ExpiryOn the carton, blister or label.
    • 28/02/2026
    • 31/03/2026
    • 30/04/2026
    First distributedOn the product, its label or its packaging.
    • 20/09/2023
    • 29/08/2024
    • 19/09/2024
    • 31/10/2024
    • 15/01/2025
    • 31/01/2025
    • 11/02/2025
    • 17/02/2025
    • 25/02/2025
    • 11/03/2025
    • 31/03/2025
    • 02/04/2025
    • 08/04/2025
    • 24/04/2025
    • 30/04/2025
    • 16/04/2025
    • 20/05/2025
    • 11/06/2025
    • 13/06/2025

What to do now

The issue with Fexofenadine Hydrochloride 120mg film-coated tablets, Chanelle Medical is information: something on the packaging or leaflet is wrong or missing.

  1. Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
  2. Compare the batch number printed on the box or label with the batches listed here.
  3. If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
  4. Any side effect you think is linked can be reported through the Yellow Card scheme.

Why it matters. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.

Symptoms and when to get help

Look out for

  • a side effect you have not had before
  • your condition not being controlled as well as usual

Get help urgently

  • signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
  • if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111

This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.

Replacements and prescriptions

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.

If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/41). Quoted as issued.

Summary

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.

The risk

DMRC reference number DMRC - 36081293 Marketing Authorisation Holder

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.

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

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.

Open the MHRA notice

Questions

Why has Fexofenadine Hydrochloride 120mg film-coated tablets, Chanelle Medical been recalled?

The issue with Fexofenadine Hydrochloride 120mg film-coated tablets, Chanelle Medical is information: something on the packaging or leaflet is wrong or missing. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.

How do I know if my medicine is affected?

Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.

What should I do now?

Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.

Do I need a new prescription?

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

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