Class 4 defect information: Amoxicillin 500mg Capsules BP (MDR 92-12/18)
Accord Healthcare Limited has informed us that that a change to the Patient Information Leaflet (PIL) for this product has not been implemented by the required timeline.
Product information MDR number MDR 92-12/18
Company name
Accord Healthcare Limited
Product description
Amoxicillin 500mg Capsules
PL 20075/0264
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| MP 18062 | 01/ 2021 | 1 x 21 | 04 Oct 2018 |
| MP 18063 | 01/ 2021 | 1x 1 x 21 | 26 Oct 2018 |
| MP 18064 | 01/ 2021 | 1x 1 x 21 | 16 Oct 2018 |
Brief description of the problem
Accord Healthcare Limited has informed us 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 healthcare professionals
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 from the link below:
https://www.medicines.org.uk/emc/product/6109/pil
Further Information
For medical information enquiries, please contact Accord Medical Information, Tel 01271 385257; email medinfo@accord-healthcare.com
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574