其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Reckitt Benckiser Healthcare (UK) Limited, Lemsip Max Cold and Flu Capsules (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Reckitt Benckiser Healthcare (UK) Limited has informed the MHRA that a typographical error has been identified on the end flap of the outer carton of 9 batches of Lemsip Max Cold and Flu Capsules (paracetamol, caffeine and phenylephrine hydrochloride) (batch number: AED954, AED955, AED956, AED957, AED958, AED960, AED961, AED981 and AEE003). The content of paracetamol per capsule was stated as 500g (grams) instead of 500mg (milligrams). The paracetamol content of each capsule is correctly stated in Patient Information Leaflet (PIL).
Healthcare professionals should note that there is no risk to product quality and/or efficacy, therefore the affected batches are not being recalled. Where queries are received regarding the discrepancy with the paracetamol content on the outer carton, healthcare professionals and retailers should signpost patients to Section 6 of the PIL, which states the correct content of paracetamol as 500mg (milligrams). Patients should also be reminded to follow the dosing instructions on the outer carton and/or Section 3 of the PIL to ensure that the recommended dose is not exceeded.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-reckitt-benckiser-healthcare-uk-limited-lemsip-max-cold-and-flu-capsules-el-23-a-slash-04
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Feb 23, 2023
Issued at HKT 14:30
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