Batch BeaconUK recalls and safety alerts

Medicines recallMHRA

Posaconazole Biocon 100mg Gastro-resistant Tablets recalled over an impurity

Impurity above limitsMedium riskClass 3

Biocon Pharma UK Limited are recalling a specific of batch Posaconazole 100mg Gastro-resistant Tablets due to an out of trend result for unspecified impurities during testing for stability.

Check your product

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

4 identifiers listed for this notice.

  • Posaconazole Biocon 100mg Gastro-resistant Tablets 12 x 8

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • BF22004504
    Product licenceThe PL number on the carton.
    • PL 50674/0011
    ExpiryOn the carton, blister or label.
    • Dec-24
    First distributedOn the product, its label or its packaging.
    • 27 April 2023

What to do now

An impurity has been found in Posaconazole Biocon 100mg Gastro-resistant Tablets at a level above what is allowed.

  1. Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
  2. Compare the batch number printed on the box or label with the batches listed here.
  3. If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
  4. Any side effect you think is linked can be reported through the Yellow Card scheme.

Why it matters. Limits for impurities are set for lifetime exposure, so short-term use is unlikely to cause harm. Recalls of this kind are usually precautionary.

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(23)A/44). Quoted as issued.

Summary

Biocon Pharma UK Limited are recalling a specific of batch Posaconazole 100mg Gastro-resistant Tablets due to an out of trend result for unspecified impurities during testing for stability.

The risk

MDR number MDR 090-12/23 Company name

Advice for healthcare professionals

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

No further action is required by patients, these batches are being recalled at the pharmacy and wholesaler level as a precautionary measure. 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 further action is required by patients, these batches are being recalled at the pharmacy and wholesaler level as a precautionary measure. 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 Posaconazole Biocon 100mg Gastro-resistant Tablets been recalled?

An impurity has been found in Posaconazole Biocon 100mg Gastro-resistant Tablets at a level above what is allowed. Limits for impurities are set for lifetime exposure, so short-term use is unlikely to cause harm. Recalls of this kind are usually precautionary.

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?

Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.

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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