Medicines recallMHRA
Suprefact 1 mg/ml solution for injection (Cheplapharm – Canadian Livery) recalled over a quality concern
Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure.
Check your product
Only products that match these details are covered. Have your pack in front of you.
3 identifiers listed for this notice.
Suprefact 1 mg/ml solution for injection (Cheplapharm – Canadian Livery) 2 multi-dose vials of 5.5ml
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- 3F022A
- ExpiryOn the carton, blister or label.
- 12/2024
- First distributedOn the product, its label or its packaging.
- 11 April 2024
What to do now
A quality problem has been identified with Suprefact 1 mg/ml solution for injection.
- Keep taking your medicine unless a healthcare professional tells you otherwise.
- Check the batch number and expiry date on your pack against the list on this page.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA 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
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.
An affected pack bought over the counter can be returned to where you bought it.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/14). Quoted as issued.
Summary
Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure.
The risk
MDR number MDR 191-04/24 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.
Wholesalers are also requested to check stock of Buserelin 1 mg/ml solution for injection for any packs that match Suprefact 1 mg/ml solution for injection (MAH: Cheplapharm – Canadian Livery) as per the product images below.
No further action is required by patients as this is a Pharmacy and Wholesaler level recall. 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 as this is a Pharmacy and Wholesaler level recall. 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 Suprefact 1 mg/ml solution for injection been recalled?
A quality problem has been identified with Suprefact 1 mg/ml solution for injection. 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, 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?
Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.
Do I need a new prescription?
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.