Batch BeaconUK recalls and safety alerts

Medicines defect noticeMHRA

Trazodone Hydrochloride 50mg/5ml Oral Solution defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Cygnus Pharma Ltd. Have informed MHRA that the European Article Number (EAN) barcode printed on various packs of Trazodone Hydrochloride 50mg/5ml Oral Solution, is defective and returns the incorrect information.

Check your product

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

5 identifiers listed for this notice.

  • Trazodone Hydrochloride 50mg/5ml Oral Solution 120 ml

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • AS240145A
    • AS240146A
    Product licenceThe PL number on the carton.
    • PL 49255/0004
    ExpiryOn the carton, blister or label.
    • 03/2027
    First distributedOn the product, its label or its packaging.
    • May 2024

What to do now

There is an error on the label, carton or patient leaflet for Trazodone Hydrochloride 50mg/5ml Oral Solution.

  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. 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/16). Quoted as issued.

Summary

Cygnus Pharma Ltd. Have informed MHRA that the European Article Number (EAN) barcode printed on various packs of Trazodone Hydrochloride 50mg/5ml Oral Solution, is defective and returns the incorrect information.

The risk

MDR number MDR 260-04/24 Company name

Advice for healthcare professionals

The product quality and safety is not affected by this issue. The 2D barcode contains the correct information. Do not use the product with any automated prescribing or dispensing systems that use the EAN barcode.

The notification is intended to make wholesalers/retailers/pharmacies aware of the barcode discrepancy for the batches specified in the tablet and to confirm that the product quality and safety has not impacted by this discrepancy.

The product quality and safety are not affected by this issue. Patients should continue to take medicines from these batches 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

The product quality and safety are not affected by this issue. Patients should continue to take medicines from these batches 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 Trazodone Hydrochloride 50mg/5ml Oral Solution been recalled?

There is an error on the label, carton or patient leaflet for Trazodone Hydrochloride 50mg/5ml Oral Solution. 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?

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.

Related notices