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Medicines defect noticeMHRA

Propantheline Tablets 15mg (Genesis Pharmaceuticals livery) defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Chelonia Healthcare Limited has informed the MHRA that an error relating to the product description was identified in the Patient Information Leaflet (PIL) for the batches listed in this notification.

Check your product

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

19 identifiers listed for this notice.

  • Propantheline Tablets 15mg (Genesis Pharmaceuticals livery) 112 tablets

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 2308089
    • 2308090
    • 2402100
    • 2402106
    • 2402111
    • 2402112
    • 2402107
    • 2402108
    • 2402109
    • 2402110
    Product licenceThe PL number on the carton.
    • PL 33414/0094
    ExpiryOn the carton, blister or label.
    • Jul-26
    • Jan-27
    • Feb-27
    First distributedOn the product, its label or its packaging.
    • 29-Jan-2024
    • 07-Feb-2024
    • 30-May-2024
    • 01-Jun-2024
    • 24-Jun-2024

What to do now

There is an error on the label, carton or patient leaflet for Propantheline Tablets 15mg (Genesis Pharmaceuticals livery).

  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/27). Quoted as issued.

Summary

Chelonia Healthcare Limited has informed the MHRA that an error relating to the product description was identified in the Patient Information Leaflet (PIL) for the batches listed in this notification.

The risk

DMRC Reference Number DMRC-30829551 Company name

Advice for healthcare professionals

There is no risk to product quality or safety because of this issue. Therefore the affected batches are not being recalled. Due to supply considerations, batches 2402107, 2402108, 2402109 and 2402110 have been recently distributed and were not repackaged with the updated PIL prior to distribution. Chelonia Healthcare Limited has confirmed that all future batches of the product will contain an updated PIL.

Healthcare professionals, including those involved in prescribing and dispensing, should note the correct description of the tablets as “round and convex in shape, and orange in colour”, as shown in the images below.

Patients do not need to take any action. The medicine itself is not affected. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients receiving the medicine via dosette boxes should continue to take the medicine in line with their prescription.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme .

Advice for patients

Patients do not need to take any action. The medicine itself is not affected. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients receiving the medicine via dosette boxes should continue to take the medicine in line with their prescription.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme .

Open the MHRA notice

Questions

Why has Propantheline Tablets 15mg (Genesis Pharmaceuticals livery) been recalled?

There is an error on the label, carton or patient leaflet for Propantheline Tablets 15mg (Genesis Pharmaceuticals livery). 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, product licence, 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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