Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Notification: Erythromycin Stearate BP 250mg Tablets, Amdipharm UK Ltd |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Amdipharm UK Ltd has informed MHRA that the Patient information leaflet (PIL) in the cartons for the batch of Erythromycin Stearate BP 250mg Tablets (Erythrocin 250 Tablets) (batch number: 6104532) includes a superseded PIL. The superseded PIL used in Batch 6104532 is missing important updated safety information, as per the recommendation from Pharmacovigilance Risk Assessment Committee (PRAC).
Amdipharm UK Ltd has confirmed that 4515 packs of the affected batch are already distributed in the market and 6823 packs are awaiting distribution. Due to supply considerations the remaining packs (6823 units) will continue to be distributed. The updated PIL is available on the website of electronic medicines compendium (eMC). For details of the missing infomration from latest PIL, please refer to the website in MHRA below.
There is no risk to product quality or impact to safety of the medicines listed in this notification because of this missing information. Healthcare professionals are advised to review the information contained within this notification and take this into account when dispensing this product. If the medicines listed in this notification are dispensed, ensure that patients are aware of the missing information. Hard copies of the correct PIL will be provided by the Marketing Authorisation Holder upon request, so that any of the affected packs remaining in the dispensary can be supplemented with the correct PIL.
The product is used to prevent and treat infections such as throat and sinus infections, chest infections, ear infections, mouth and dental infections and other infections as specified in the PIL.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-erythromycin-stearate-bp-250mg-tablets-amdipharm-uk-ltd-el-25-a-slash-32
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Jul 2, 2025
Issued at HKT 18:00
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