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Medicines defect noticeMHRA

Cozaar 100mg film-coated tablets defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Quadrant Pharmaceuticals Ltd has informed the MHRA of an error with the Patient Information Leaflets (PILs) in the listed batches of Cozaar 100mg film-coated tablets.

Check your product

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

16 identifiers listed for this notice.

  • Cozaar 100mg film-coated tablets 28

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 6016W
    • 5584W
    • 5393W
    • 5474W
    • 5169W
    • 5164W
    • 5171W
    ExpiryOn the carton, blister or label.
    • 31/08/2025
    • 31/03/2025
    • 30/06/2025
    First distributedOn the product, its label or its packaging.
    • 08/11/2023
    • 23/10/2023
    • 18/10/2023
    • 11/10/2023
    • 10/10/2023
    • 06/10/2023

What to do now

There is an error on the label, carton or patient leaflet for Cozaar 100mg film-coated tablets.

  1. Keep taking your medicine unless a healthcare professional tells you otherwise.
  2. Check the batch number and expiry date on your pack against the list on this page.
  3. If it matches, your pharmacist can swap it or arrange an alternative.
  4. Report suspected side effects to the MHRA 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

If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself.

Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/01). Quoted as issued.

Summary

Quadrant Pharmaceuticals Ltd has informed the MHRA of an error with the Patient Information Leaflets (PILs) in the listed batches of Cozaar 100mg film-coated tablets.

The risk

MDR Number MDR 197-11/23 Company name

Advice for healthcare professionals

There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the products and where possible, provide an updated PIL.

The updated PIL is available here: https://www.medicines.org.uk/emc/product/7798/pil or by contacting licensing@maxearn.co.uk

If it is not possible to provide an updated PIL please advise patients of the missing information and discuss with them whether the medicine is suitable for them. Quadrant Pharmaceuticals Ltd has confirmed that all future imported batches will contain the correct PIL.

Upon request, Quadrant Pharmaceuticals Ltd will post hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information.

Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients are advised that grapefruit juice should be avoided while taking Cozaar.

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 .

Advice for patients

Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients are advised that grapefruit juice should be avoided while taking Cozaar.

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 .

Open the MHRA notice

Questions

Why has Cozaar 100mg film-coated tablets been recalled?

There is an error on the label, carton or patient leaflet for Cozaar 100mg film-coated tablets. 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?

Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.

Do I need a new prescription?

If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself. Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.

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