MHRA Class 4 Medicines Defect Information: Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml)

Class 4 Medicines Defect Information: Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml) Galderma (U.K.) Limited

Drug alert number: EL (23)A/31

Date issued: 29 August 2023

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml) Galderma (U.K.) Limited.

Company name: Galderma (U.K.) Limited

Product name: Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml), PL 10590/0042

SNOMED Code: 757311000001109

Active Pharmaceutical Ingredient: 5% w/v amorolfine in the form of hydrochloride

Brief description of the problem

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. Although Loceryl is a registered medicine in both Ireland and the UK, there are differences between these products in the product labelling and Patient Information Leaflet (PIL) packaged with the medicine.

Details of the key packaging differences for Ireland (under Irish product authorisation number PA 22743/009/001; *SKU number 023299) versus the UK product (PL 10590/0042; SKU number 023271), which the company and MHRA have risk assessed as having minimal safety implications for the patient, are described below.

Bottle Labelling

• The bottle label should state the requirement to protect the product from heat.

PIL Section 2 (‘What you need to know before you use Loceryl’)

• The instruction, in the event of a serious allergic reaction (a reaction which is described above the warnings and precautions section), to ‘stop applying the product, immediately remove the product with a nail varnish remover or the cleaning swabs provided with the package’ is missing.
• ‘Tongue or throat swelling’ is missing from the serious allergic reaction symptoms above the warnings and precautions section.
• The statement “One gram of Loceryl contains 552 mg of alcohol (ethanol), which is equivalent to 55.2 % w/w. It may cause a burning a sensation on damaged skin. Ethanol is a flammable substance and should not be used near an open flame, a lit cigarette or some devices (e.g. hair dryers).” is missing from the ‘Important information about some of the ingredients’ section. However, the ‘Possible side effects’ section of the PIL (section 4) does forewarn that a burning sensation may occur in the area around the nail (with a frequency of very rare) and the patient is instructed (in PIL section 5 – ‘How to store Loceryl’) to keep the pack away from heat.

PIL Section 4 (‘Possible side effects’)

• ‘Systemic allergic reaction (a serious allergic reaction that can be associated with swelling of the face, lips, tongue or throat, difficulty breathing and/or a severe skin rash)’ wording is missing from the ‘Unknown frequency of occurrence’ section.
• The contact details provided in the leaflet for reporting side effects/adverse events relate to the Irish authority (HPRA) rather than the UK authority (MHRA).

Administrative details

• The carton, bottle label and PIL display the Marketing Authorisation Holder (MAH) name and address and Marketing Authorisation (MA) number as registered in Ireland rather than those registered in the UK.

View full alert here.

Further Information

If you require more information, have further medical information enquiries (including replacement PIL enquiries) then please e-mail: medinfo.uk@galderma.com. For stock control queries, please contact: sales.uk@galderma.com