Medicines defect noticeMHRA
Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension defect notice over a quality concern
Atnahs Pharma UK Ltd has informed the MHRA that the batches of Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension listed in this notification do not contain the most up to date safety information.
Check your product
Only products that match these details are covered. Have your pack in front of you.
8 identifiers listed for this notice.
Product 1 5mg/5ml
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- 230001
- Product licenceThe PL number on the carton.
- PL 43252/0010
- PL 43252/0011
- ExpiryOn the carton, blister or label.
- 01.2025
- First distributedOn the product, its label or its packaging.
- 15.06.2023
Product 2 10mg/5ml
- Batch code
- 230002
- Expiry
- 03.2025
- First distributed
- 19.07.2023
What to do now
A quality problem has been identified with Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension.
- 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.
- If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
- 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
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(23)A/43). Quoted as issued.
Summary
Atnahs Pharma UK Ltd has informed the MHRA that the batches of Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension listed in this notification do not contain the most up to date safety information.
The risk
MDR number MDR 008-11/23 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 check if patients belong to any of the groups at risk and provide advice accordingly or do not prescribe and/or dispense this product. Where appropriate, healthcare professionals should provide a copy of the PIL when supplying any remaining stock to patients.
A copy of the correct SmPC and PIL can be found in the following links:
SmPC Clobazam Atnahs 5mg/5ml Oral Suspension: https://www.medicines.org.uk/emc/product/721/smpc
SmPC Clobazam Atnahs 10mg/5ml Oral Suspension: https://www.medicines.org.uk/emc/product/7618/smpc
PIL Clobazam Atnahs 5mg/5ml &10mg/5ml Oral Suspension: https://www.medicines.org.uk/emc/files/pil.7618.pdf
Atnahs Pharma UK Ltd has also confirmed that all remaining packs of the impacted batches will not be distributed and that all future batches will contain the updated PIL. Upon request, the manufacturer 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 from the end of Jan 2024.
This issue is about missing information on the Patient Information Leaflets (PILs) and Summary of Product Characteristics (SmPC). The medicine itself is not affected and therefore patients do not need to take any specific action relating to the product. If you have any concerns, talk to your doctor. If you are pregnant (or planning to have a baby), suffering from depression or other psychological illnesses, please speak to a doctor before continuing to take this medication. A copy of the correct Patient Information Leaflet containing the latest safety information for Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension can be found in the following link:
https://www.medicines.org.uk/emc/files/pil.7618.pdf
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
This issue is about missing information on the Patient Information Leaflets (PILs) and Summary of Product Characteristics (SmPC). The medicine itself is not affected and therefore patients do not need to take any specific action relating to the product. If you have any concerns, talk to your doctor. If you are pregnant (or planning to have a baby), suffering from depression or other psychological illnesses, please speak to a doctor before continuing to take this medication. A copy of the correct Patient Information Leaflet containing the latest safety information for Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension can be found in the following link:
https://www.medicines.org.uk/emc/files/pil.7618.pdf
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 Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension been recalled?
A quality problem has been identified with Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension. 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?
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.