Other safety alerts
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| The United Kingdom: Class 4 defect information: Amoxicillin 500mg Capsules BP |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Accord Healthcare Limited has informed MHRA that a change to the Patient Information Leaflet (PIL) for Amoxicillin 500mg Capsules has not been implemented by the required timeline. The change concerns the addition of the symptoms of a potential side effect, ‘Drug Reaction with Eosinophilia and Systemic Symptoms’ (DRESS) which is a potentially life-threatening condition. For this reason, it is important that any patients who notice the symptoms seek immediate medical advice. The affected batches are:
- Batch number: MP 18062; Expiry date: 01/ 2021
- Batch number: MP 18063; Expiry date: 01/ 2021
- Batch number: MP 18064; Expiry date: 01/ 2021
Healthcare professionals are advised that when dispensing this product, please check the Marketing Authorisation Holder and the batch number. If any of the above batch numbers are being dispensed, please remove the PIL in the pack and provide a copy of the correct version.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-defect-information-amoxicillin-500mg-capsules-bp-mdr-92-12-18
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Feb 8, 2019
Issued at HKT 16:00
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