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Medicines defect noticeMHRA

Zoledronic Acid Ennogen 4mg/5ml concentrate for solution for infusion defect notice over a quality concern

Medicine quality concernLow riskClass 4

Ennogen Healthcare Limited has identified that action had not been taken to ensure the Patient Reminder Card (PRC) was distributed alongside the packs of product as part of the approved Additional Risk Minimisation Measures (RMM).

Check your product

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

11 identifiers listed for this notice.

  • Zoledronic Acid Ennogen 4mg/5ml concentrate for solution for infusion 1 x 5ml

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 35000341
    • 35000387
    • 35000389
    • 35000390
    Product licenceThe PL number on the carton.
    • PL 40739/0233
    • PL40739/0233
    ExpiryOn the carton, blister or label.
    • Apr-25
    • Nov-25
    First distributedOn the product, its label or its packaging.
    • 01 Sep 2023
    • 26 Jan 2024
    • 16 Feb 2024

What to do now

Affected batches of Zoledronic Acid Ennogen 4mg/5ml concentrate for solution for infusion are subject to a recall or defect notice.

  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. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.

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

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.

If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/53). Quoted as issued.

Summary

Ennogen Healthcare Limited has identified that action had not been taken to ensure the Patient Reminder Card (PRC) was distributed alongside the packs of product as part of the approved Additional Risk Minimisation Measures (RMM).

The risk

DMRC reference number DMRC-33615243 Company name

Advice for healthcare professionals

Ennogen Healthcare Limited confirm that there is sufficient information available to the healthcare professionals administering the medicine via the PIL: Zolendronic Acid Leaflet_08-07-24_v5.cdr (medicines.org.uk) , SmPC: Zoledronic acid Ennogen 4 mg/5 ml concentrate for solution for infusion - Summary of Product Characteristics (SmPC) - print friendly - (emc) (medicines.org.uk) , BNF: Zoledronic acid / Drugs / BNF / NICE to ensure that the relevant cautions whilst taking the medicine and risks associated with ONJ can be discussed during consultation, to make the patient aware of the specific precautions to be taken before and during treatment.

Healthcare professionals can access the electronic versions of the PRC .

Alternatively healthcare professionals may contact Ennogen Healthcare Limited directly to obtain copies of the PRC for distribution to patients via their clinics by e-mailing MedicalInformation@ennogen.com

Patients being administered the product from the above specified batches should either be provided a link to the online copy of the PRC or given a hard copy.

Patients should continue to take medicines from these batches as administered by your healthcare professional. This does not affect the quality of the product.

The Patient Reminder Card is an additional measure to ensure ongoing understanding for the patient of risks associated with osteonecrosis of the jaw during treatment.

If you have any concerns about the information provided with your medicine, please speak to your consultant or GP in the first instance.

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

Patients should continue to take medicines from these batches as administered by your healthcare professional. This does not affect the quality of the product.

The Patient Reminder Card is an additional measure to ensure ongoing understanding for the patient of risks associated with osteonecrosis of the jaw during treatment.

If you have any concerns about the information provided with your medicine, please speak to your consultant or GP in the first instance.

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 Zoledronic Acid Ennogen 4mg/5ml concentrate for solution for infusion been recalled?

Affected batches of Zoledronic Acid Ennogen 4mg/5ml concentrate for solution for infusion are subject to a recall or defect notice. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.

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?

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

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