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Medicines defect noticeMHRA

Tostran (Testosterone, 2% gel) defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Kyowa Kirin Limited has notified MHRA that the priming instructions in the current PIL for Tostran 2% gel require updating.

Check your product

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

13 identifiers listed for this notice.

  • Tostran (Testosterone, 2% gel) 60g

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 2649810
    • 2649850
    • 2649860
    • 2649820
    • 2661080
    • 2661090
    • 2650030
    Product licenceThe PL number on the carton.
    • PL 16508/0025
    ExpiryOn the carton, blister or label.
    • 11/2024
    • 12/2024
    • 02/2025
    • 01/2025
    First distributedOn the product, its label or its packaging.
    • September-2023

What to do now

There is an error on the label, carton or patient leaflet for Tostran (Testosterone, 2% gel).

  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(23)A/33). Quoted as issued.

Summary

Kyowa Kirin Limited has notified MHRA that the priming instructions in the current PIL for Tostran 2% gel require updating.

The risk

MDR number MDR 013-08/23 Company name

Advice for healthcare professionals

Healthcare professionals are advised to inform patients that there was a change to the pump/dispenser device supplied with this medicine and the priming instructions prior to use in the current PIL are not accurate.

Advise patients that priming should performed before first use as follows:

With the canister in the upright position, slowly and fully depress and release the actuator until gel is dispensed.

Slowly depress and release the actuator a further 6 times.

Discard the gel from the 6 depressions safely in household waste (outside of reach of children or pets).

Deliver the dose as instructed by a healthcare professional and follow the instructions to prevent accidental transfer to others.

It is only necessary to prime the pump before the first dose. There have been no changes to the content of the canister or the quality of the gel. The device continues to deliver a total of 120 active dose pumps, each dispensing 0.5g of gel (equivalent to 10 mg of testosterone). The storage conditions specified on the pack remain correct.

The change to the priming instruction is considered a low risk to patient safety. To avoid shortages of this medicine, Kyowa Kirin Limited intend to distribute these batches whilst the new PIL is being assessed.

Patients are advised that there are new instructions for patients using Tostran (Testosterone, 2% gel). For the batches impacted, and all future manufacture, more pumps are required to prime the device before using it for the first time. If these instructions are not followed then a less accurate first dose may be delivered.

Patients should continue to take medicines from these batches as prescribed by your healthcare professional but use the following instructions to prime the pump before using this product for the first time:

With the canister in the upright position, slowly and fully depress and release the actuator until gel is dispensed.

Depress and release the actuator a further 6 times.

Advice for patients

Patients are advised that there are new instructions for patients using Tostran (Testosterone, 2% gel). For the batches impacted, and all future manufacture, more pumps are required to prime the device before using it for the first time. If these instructions are not followed then a less accurate first dose may be delivered.

Patients should continue to take medicines from these batches as prescribed by your healthcare professional but use the following instructions to prime the pump before using this product for the first time:

With the canister in the upright position, slowly and fully depress and release the actuator until gel is dispensed.

Depress and release the actuator a further 6 times.

Discard the gel from the 6 depressions in household waste (outside the reach of children or pets).

Deliver the dose as instructed by a healthcare professional and follow the instructions to prevent accidental transfer to others.

Note, It is only necessary to prime the pump before the first dose. Following priming, the device will deliver a total of 120 active dose pumps.

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 Tostran (Testosterone, 2% gel) been recalled?

There is an error on the label, carton or patient leaflet for Tostran (Testosterone, 2% gel). 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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