Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Epiduo 0.1% ／ 2.5% gel (45 g) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Galderma (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in 15 batches of Epiduo 0.1% / 2.5% gel (adapalene / benzoyl peroxide) (batch number: 1324283, 1324288, 2324207, 2324212, 2324218, 2324227, 2324228, 2324228A, 2324237, 2324238, 2324239, 2324248, 2324249, 2324259, 2324265) contains outdated safety information regarding pregnancy.
The correct version of the leaflet should include the following wording in section 2 (“What you need to know before you use Epiduo”):
Do not use Epiduo:
- If you are pregnant
- If you are planning a pregnancy
Pregnancy and breast-feeding
DO NOT use Epiduo if you are pregnant or thinking of becoming pregnant. Your doctor can give you more information.
There is no risk to product quality as a result of this issue. Healthcare professionals are advised to exercise caution when dispensing the above batches of the product. Where possible, please provide an updated copy of the PIL to the patient and remind the patient to read the leaflet in its entirety before using the medicine.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-galderma-uk-limited-epiduo-0-dot-1-percent-slash-2-dot-5-percent-gel-45-g-el-22-a-slash-52
In Hong Kong, Epiduo Gel (HK-58988) is a pharmaceutical product registered by Galderma Hong Kong Limited (Galderma). The product is a prescription-only medicine. As confirmed with Galderma, the affected batches have not been imported into Hong Kong.
Ends/Tuesday, Dec 20, 2022
Issued at HKT 15:00
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