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Medicines defect noticeMHRA

Tramadol Hydrochloride 50 mg capsules defect notice over a packaging defect

Packaging or device defectLow riskClass 4

Morningside Healthcare Limited has informed the MHRA of a packaging issue identified in batch MRA2303 of Tramadol Hydrochloride Morningside 50 mg Prolonged-Release Capsules and batch MRF2301 of Tramadol Hydrochloride 50 mg Capsules.

Check your product

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

8 identifiers listed for this notice.

  • Product 1 60

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • MRA2303
    Product licenceThe PL number on the carton.
    • PL 20117/0384
    • PL 20117/0086
    ExpiryOn the carton, blister or label.
    • 05/2026
    First distributedOn the product, its label or its packaging.
    • 30/01/2024

  • Product 2 30

    Batch code
    • MRF2301
    Expiry
    • 11/2027
    First distributed
    • 06/08/2024

What to do now

A fault with the packaging or delivery device of Tramadol Hydrochloride 50 mg capsules has been found.

  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

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/57). Quoted as issued.

Summary

Morningside Healthcare Limited has informed the MHRA of a packaging issue identified in batch MRA2303 of Tramadol Hydrochloride Morningside 50 mg Prolonged-Release Capsules and batch MRF2301 of Tramadol Hydrochloride 50 mg Capsules.

The risk

DMRC reference number DMRC-33916753 Company name

Advice for healthcare professionals

Caution should be exercised when dispensing Tramadol Hydrochloride Morningside 50 mg Prolonged-Release Capsules from these batches. Cartons should be opened and each blister strip inspected to confirm the presence of 10 capsules per strip before dispensing.

If missing capsules are identified, this should be reported to Morningside Healthcare Limited via the contact details below and the packs returned through your supplier’s approved process. Morningside will reimburse the wholesaler accordingly.

Patients are advised that some packs may contain missing capsules. This issue affects packs with the batch numbers specified in the table. If you find missing capsules in your pack, please speak to your medicine provider immediately for further advice. The medicine itself is not affected, there are no concerns about the quality or efficacy of the capsules that are present.

If you experience any unexpected side effects or adverse reactions, these should be reported via the MHRA Yellow Card Scheme at https://yellowcard.mhra.gov.uk .

Advice for patients

Patients are advised that some packs may contain missing capsules. This issue affects packs with the batch numbers specified in the table. If you find missing capsules in your pack, please speak to your medicine provider immediately for further advice. The medicine itself is not affected, there are no concerns about the quality or efficacy of the capsules that are present.

If you experience any unexpected side effects or adverse reactions, these should be reported via the MHRA Yellow Card Scheme at https://yellowcard.mhra.gov.uk .

Open the MHRA notice

Questions

Why has Tramadol Hydrochloride 50 mg capsules been recalled?

A fault with the packaging or delivery device of Tramadol Hydrochloride 50 mg capsules has been found. 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, 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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