Medicines defect noticeMHRA
Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml) defect notice over a quality concern
Galderma (U.K.) Limited has informed the MHRA that a pallet of Loceryl 5% w/v Medicated Nail Lacquer from a batch licensed only for distribution in Ireland has been inadvertently placed into the UK supply chain due to a warehousing error at their UK pre-wholesaler.
Check your product
Only products that match these details are covered. Have your pack in front of you.
4 identifiers listed for this notice.
Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml) 1 x 5.0ml
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- 2212421*
- Product licenceThe PL number on the carton.
- PL 10590/0042
- ExpiryOn the carton, blister or label.
- 05 / 2025
- First distributedOn the product, its label or its packaging.
- 19 August 2022
What to do now
Affected batches of Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml) are subject to a recall or defect notice.
- 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
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(23)A/31). Quoted as issued.
Summary
Galderma (U.K.) Limited has informed the MHRA that a pallet of Loceryl 5% w/v Medicated Nail Lacquer from a batch licensed only for distribution in Ireland has been inadvertently placed into the UK supply chain due to a warehousing error at their UK pre-wholesaler.
The risk
MDR number MDR 087-06/23 Company name
Advice for healthcare professionals
Healthcare professionals are advised to exercise caution when dispensing the above batch of Loceryl 5% w/v Medicated Nail Lacquer (as packaged in the Irish livery). Where possible, please provide the current UK-approved copy of the PIL to the patient and remind the patient to read the leaflet in its entirety before using the medicine. Please reiterate to patients that this product contains ethanol, which is a flammable substance, and should not be used near an open flame, a lit cigarette or some devices (for example, hair dryers).
The Marketing Authorisation Holder can supply copies of the correct PIL on request; a copy of the UK PIL is available via the following link: Loceryl 5% w/v Medicated Nail Lacquer - Patient Information Leaflet (PIL) - (emc) (medicines.org.uk)
There is missing information from the Patient Information Leaflet that accompanies certain packs of batch 2212421 of Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml) – i.e. the Irish packs inadvertently distributed in the UK. The missing information has been detailed in this notification.
You can ask your pharmacist for a copy of the correct leaflet or you can download it directly . Please ensure that you read the information on the packaging and in the leaflet carefully before using the product.
If you experience symptoms of a systemic allergic reaction while using the medicated nail lacquer (swelling of the face, lips, tongue or throat, difficulty breathing and/or a severe skin rash) then you should stop applying the product and immediately remove it with a nail varnish remover or the cleaning swabs provided with the package. Always seek medical advice if you have an allergic reaction.
Loceryl medicated nail lacquer also contains ethanol. Ethanol is a flammable substance and should not be used near an open flame, a lit cigarette or some devices (for example, hair dryers).
Loceryl is a Prescription Only Medicine (POM), (medicines that have to be prescribed by a doctor or other authorised health professional), and should be used as directed. If you have any questions, please consult your GP or pharmacist. Any suspected adverse reactions or side effects should be reported to the MHRA’s Yellow Card scheme.
Advice for patients
There is missing information from the Patient Information Leaflet that accompanies certain packs of batch 2212421 of Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml) – i.e. the Irish packs inadvertently distributed in the UK. The missing information has been detailed in this notification.
You can ask your pharmacist for a copy of the correct leaflet or you can download it directly . Please ensure that you read the information on the packaging and in the leaflet carefully before using the product.
If you experience symptoms of a systemic allergic reaction while using the medicated nail lacquer (swelling of the face, lips, tongue or throat, difficulty breathing and/or a severe skin rash) then you should stop applying the product and immediately remove it with a nail varnish remover or the cleaning swabs provided with the package. Always seek medical advice if you have an allergic reaction.
Loceryl medicated nail lacquer also contains ethanol. Ethanol is a flammable substance and should not be used near an open flame, a lit cigarette or some devices (for example, hair dryers).
Loceryl is a Prescription Only Medicine (POM), (medicines that have to be prescribed by a doctor or other authorised health professional), and should be used as directed. If you have any questions, please consult your GP or pharmacist. Any suspected adverse reactions or side effects should be reported to the MHRA’s Yellow Card scheme.
Open the MHRA notice
Questions
Why has Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml) been recalled?
Affected batches of Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml) 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?
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?
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.