其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Doncaster Pharma Limited, Keppra 500mg film-coated tablets (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Doncaster Pharma Limited have identified an error relating to the Braille printed on the cartons on various parallel imported packs which have been repackaged by BModesto B.V. Approximately 70% of the packs across the listed batches have been repackaged with the Braille message on the Keppra 500mg film-coated tablets incorrectly stating strength as 1000mg. For details of the affected batch numbers, please refer to the website in MHRA.
There is no issue with the quality of the tablets, therefore, the affected batches are not being recalled. MHRA would advise healthcare professionals to check, before dispensing the medication, whether patients or carers handling or taking the medication will be relying on the Braille. Where this is the case, alternative batches should be dispensed to avoid confusion and subsequent underdosing.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-doncaster-pharma-limited-keppra-500mg-film-coated-tablets-el-24-a-slash-15
In Hong Kong, Keppra Tab 500mg (HK-48231) is a pharmaceutical product registered by Glaxosmithkline Limited (GSK). The product is a prescription-only medicine. As confirmed with GSK, the packaging of the above registered product in Hong Kong does not contain the related Braille message.
Ends/Thursday, May 16, 2024
Issued at HKT 16:55
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