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Medicines defect noticeMHRA

Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution defect notice over a packaging defect

Packaging or device defectLow riskClass 4

Zydus Pharmaceuticals UK LTD has informed the MHRA that there is an error on the artwork for the outer carton and Patient Information Leaflet (PIL) of Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution (pack size 150ml and 280ml bottles).

Check your product

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

7 identifiers listed for this notice.

  • Product 1 280ml

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • TPR24001
    • TPR24002
    ExpiryOn the carton, blister or label.
    • Jun-26
    First distributedOn the product, its label or its packaging.
    • 11/Nov/2024

  • Product 2 150ml

    Batch code
    • TPR24003
    Expiry
    • Sep-26
    First distributed
    • 29/Nov/2024

What to do now

The problem with Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution, Zydus is the pack or device, such as a syringe, cap, blister or inhaler.

  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. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

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/39). Quoted as issued.

Summary

Zydus Pharmaceuticals UK LTD has informed the MHRA that there is an error on the artwork for the outer carton and Patient Information Leaflet (PIL) of Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution (pack size 150ml and 280ml bottles).

The risk

DMRC reference number DMRC-36144551 Marketing Authorisation Holder

Advice for healthcare professionals

Healthcare professionals and retailers are advised to review the information contained within this notification and, where possible, inform customers that Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution (Pack Size 150ml and 280ml bottles) should be “shaken well prior to opening and before each use”.

Healthcare professional should continue to prescribe and dispense the product as the batches listed are not being recalled.

Please shake the bottle prior to opening and before each use. Patients in receipt of these batches should continue to take the medicine as prescribed by your healthcare professional. Never stop taking medicines such as topiramate without medical advice, especially if they are being used for epilepsy. Suddenly stopping an epilepsy medicine may cause your seizures to start again or happen more often or last longer than before. These batches are not being recalled and should not cause harm if taken without shaking

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 .

Advice for patients

Please shake the bottle prior to opening and before each use. Patients in receipt of these batches should continue to take the medicine as prescribed by your healthcare professional. Never stop taking medicines such as topiramate without medical advice, especially if they are being used for epilepsy. Suddenly stopping an epilepsy medicine may cause your seizures to start again or happen more often or last longer than before. These batches are not being recalled and should not cause harm if taken without shaking

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 Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution, Zydus been recalled?

The problem with Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution, Zydus is the pack or device, such as a syringe, cap, blister or inhaler. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

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?

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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