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Medicines recallMHRA

Loperamide Hydrochloride Capsules 2mg recalled over possible contamination

Contamination or sterilityHigh riskClass 2

Strides Pharma UK Ltd is recalling the listed batch as a precautionary measure due to an out of specification result for microbial contamination, reported during retesting.

Check your product

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

4 identifiers listed for this notice.

  • Loperamide Hydrochloride Capsules 2mg 3 x 10

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • EG23LPA006
    Product licenceThe PL number on the carton.
    • PL 13606/0045
    ExpiryOn the carton, blister or label.
    • 06/2027
    First distributedOn the product, its label or its packaging.
    • 19 March 2024

What to do now

Loperamide Hydrochloride Capsules 2mg has been recalled because the product may not be as clean or sterile as it should be.

  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. Contamination matters most for injections, eye drops and products used on broken skin, where it could cause infection.

Symptoms and when to get help

Look out for

  • redness, swelling or pain where the product was used
  • a high temperature

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

The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.

An affected pack bought over the counter can be returned to where you bought it.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/38). Quoted as issued.

Summary

Strides Pharma UK Ltd is recalling the listed batch as a precautionary measure due to an out of specification result for microbial contamination, reported during retesting.

The risk

DMRC reference number DMRC-31480052 Company name

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all remaining stock and return it through your supplier’s approved process.

No action is required by patients as this is a Pharmacy and Wholesaler level recall. There have been no reports of patients being harmed or becoming ill from taking this medicine. Patients should continue to take medicines from this batch as prescribed by your healthcare professional.

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

No action is required by patients as this is a Pharmacy and Wholesaler level recall. There have been no reports of patients being harmed or becoming ill from taking this medicine. Patients should continue to take medicines from this batch as prescribed by your healthcare professional.

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 Loperamide Hydrochloride Capsules 2mg been recalled?

Loperamide Hydrochloride Capsules 2mg has been recalled because the product may not be as clean or sterile as it should be. Contamination matters most for injections, eye drops and products used on broken skin, where it could cause infection.

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?

The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.

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