Medicines defect noticeMHRA
Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution defect notice over a labelling error
L M Manufacturing Limited has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batch listed for Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution include an out of date PIL, dated July 2021.
Check your product
Only products that match these details are covered. Have your pack in front of you.
4 identifiers listed for this notice.
Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution 150 mL
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- OXY23001
- Product licenceThe PL number on the carton.
- PL 40496/0009
- ExpiryOn the carton, blister or label.
- Jul/2026
- First distributedOn the product, its label or its packaging.
- 30 April 2024
What to do now
A printing or labelling mistake affects some packs of Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution.
- 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. 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
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/61). Quoted as issued.
Summary
L M Manufacturing Limited has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batch listed for Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution include an out of date PIL, dated July 2021.
The risk
DMRC reference number DMRC-34033472 Company name
Advice for healthcare professionals
Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing this product Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution. When product from batch included in the table is supplied or dispensed, please ensure that patients are aware of the missing information. The electronic versions of the PIL is up to date and can be accessed via the following link:
https://www.medicines.org.uk/emc/files/pil.13841.pdf
Patients should continue to take medicines from the impacted batch as prescribed by your healthcare professional. This does not affect the quality of the product. There are warnings in the updated patient information leaflet (PIL) which accompanies the medicine, for “What you need to know before you take Oxybutynin hydrochloride Brillpharma”; “Warnings and Precautions”; “In particular tell your doctor if you are taking any of the following”; “Pregnancy, breast-feeding and fertility”; “Not known: cannot be estimated from the available data”). The updated PIL can be accessed via the following link:
https://www.medicines.org.uk/emc/files/pil.13841.pdf
If you have any concerns about the information provided with your medicine, please speak with your pharmacy team in the first instance. 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
Patients should continue to take medicines from the impacted batch as prescribed by your healthcare professional. This does not affect the quality of the product. There are warnings in the updated patient information leaflet (PIL) which accompanies the medicine, for “What you need to know before you take Oxybutynin hydrochloride Brillpharma”; “Warnings and Precautions”; “In particular tell your doctor if you are taking any of the following”; “Pregnancy, breast-feeding and fertility”; “Not known: cannot be estimated from the available data”). The updated PIL can be accessed via the following link:
https://www.medicines.org.uk/emc/files/pil.13841.pdf
If you have any concerns about the information provided with your medicine, please speak with your pharmacy team in the first instance. 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 Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution been recalled?
A printing or labelling mistake affects some packs of Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml 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?
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.