Class 4 MHRA Drug Alert – Amoxicillin 500mg capsules BP (Accord)

Class 4 MHRA Drug Alert – Amoxicillin 500mg capsules BP (Accord)

February 4, 2019

Drug Alert No: EL (19) A/03
Date Issued: 4th February 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for certain batches of Amoxicillin 500mg capsules (Accord).

Amoxicillin 500mg capsules BP (Accord)

PL 200175/0264

Batch Number Expiry Date Pack Size First Distributed
 MP 18062  01/2021  1 x 21 04 Oct 2018
 MP 18063  01/2021  1 x 21 26 Oct 2018
 MP 18064  01/2021  1 x 21 16 Oct 2018

Accord Healthcare Limited has informed MHRA that a change to the Patient Information Leaflet (PIL) for this product 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.

Advice for community pharmacy teams:

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, which can be downloaded here.

For medical information enquiries, please contact Accord Medical Information, Tel 01271 385257; email medinfo@accord-healthcare.com



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