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Medicines defect noticeMHRA

Trazodone Hydrochloride 50mg, 100mg Capsules & 50mg/5ml Oral Solution defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Dawa Limited has informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Trazodone Hydrochloride 50mg and 100mg Capsules and Trazodone Hydrochloride 50mg/5ml Oral Solution.

Check your product

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

54 identifiers listed for this notice.

  • Product 1 84

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 220191
    • 220192
    • 220193
    • 220212
    • 220340
    • 220382
    • 230259
    • 200284
    Product licenceThe PL number on the carton.
    • PL 30684/0250
    • PL 30684/0251
    • PL 30684/0268
    ExpiryOn the carton, blister or label.
    • Apr-26
    • Jun-26
    • Jul-26
    • May-27
    • Sep-24
    First distributedOn the product, its label or its packaging.
    • 01/12/2022
    • 28/11/2022
    • 03/11/2022
    • 10/10/2023
    • 11/12/2023
    • 26/02/2024
    • 23/03/2021

  • Product 2 56

    Batch code
    • 200285
    • 220194
    • 220213
    • 220214
    • 220215
    • 220237
    • 220300
    • 220341
    • 220383
    • 230260
    Expiry
    • Sep-24
    • Apr-26
    • May-26
    • Jun-26
    • Jul-26
    • May-27
    First distributed
    • 03/08/2021
    • 03/11/2022
    • 03/01/2023
    • 26/01/2023
    • 17/01/2023
    • 09/10/2023
    • 09/11/2023
    • 13/10/2023
    • 03/11/2023
    • 30/01/2024

  • Product 3 120ml

    Batch code
    • C31037
    • C31038
    Expiry
    • Sep-26
    First distributed
    • 09/04/2024
    • 30/01/2024

What to do now

There is an error on the label, carton or patient leaflet for Trazodone Hydrochloride 50mg, 100mg Capsules & 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/37). Quoted as issued.

Summary

Dawa Limited has informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Trazodone Hydrochloride 50mg and 100mg Capsules and Trazodone Hydrochloride 50mg/5ml Oral Solution.

The risk

MDR number MDR 195-05/24 Company name

Advice for healthcare professionals

There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the products and where possible, provide an updated PIL. The updated PIL is available electronically and can be downloaded from the following links:

Trazodone Hydrochloride 50mg Capsules

Trazodone Hydrochloride 100mg Capsules

Trazodone 50mg/5ml Oral Solution

If it is not possible to provide an updated PIL, please advise patients of the missing information, discuss if this medicine is still suitable for them, and the need to seek medical advice if these signs or symptoms occur.

The distributor, Drugsrus Limited, has confirmed that all future batches will contain the correct PIL. Upon request, Drugsrus Limited will post hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information (see contact details below).

No action is needed from patients. This issue is about missing information in the Patient Information Leaflets in specific batches of Trazodone Hydrochloride 50mg and 100mg Capsules and Trazodone Hydrochloride 50mg/5ml Oral Solution indicated for anxiety and depression. The medication itself is not affected.

These products will have been prescribed and dispensed by qualified healthcare professional(s) responsible for your care. If you have concerns about a medicine you may be using, please contact 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 needed from patients. This issue is about missing information in the Patient Information Leaflets in specific batches of Trazodone Hydrochloride 50mg and 100mg Capsules and Trazodone Hydrochloride 50mg/5ml Oral Solution indicated for anxiety and depression. The medication itself is not affected.

These products will have been prescribed and dispensed by qualified healthcare professional(s) responsible for your care. If you have concerns about a medicine you may be using, please contact 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, 100mg Capsules & 50mg/5ml Oral Solution been recalled?

There is an error on the label, carton or patient leaflet for Trazodone Hydrochloride 50mg, 100mg Capsules & 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.

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