Class 4 medicine defect information – Amoxicillin capsules BP 500mg

05 Feb 2019

A Class 4 medicines defect information alert has been issued by the MHRA for specific batches of Amoxicillin capsules BP 500mg manufactured by Accord Healthcare Limited

DRUG ALERT

Class 4 medicine defect information

MDR 92-12/18

4  February 2019

Amoxicillin capsules BP 500mg
(Manufactured by Accord Healthcare Limited)

PL 20075/0264

 

A Class 4 defect information has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for certain batches of Amoxicillin capsules BP 500mg as follows:

Amoxicillin capsules BP 500mg

PL 20075/0264

 Batch number Expiry date Pack size Date of first distribution
MP 18062 January 2021 1 x 21 04/10/2018
MP 18063 January 2021 1 x 1 x 21 26/10/2018
MP 18064 January 2021 1 x 1 x 21 16/10/2018

 

Accord Healthcare Limited has informed the MHRA that a change that needed to be made in the patient information leaflet (PIL) was not undertaken within the required timeframe. The change concerns adding the following potential side-effect symptom:

  • Drug Reaction with Eosinophilia and Systemic Symptoms’ (DRESS) – this condition can be potentially life-threatening and patients should seek immediate medical advice if this occurs

 Advice to healthcare professionals

Pharmacists and pharmacy teams are required to:

  1. Check the Marketing Authorisation and batch number of the amoxicillin capsules BP 500mg being dispensed
  2. If it is one of the above affected batch numbers manufactured by Accord Healthcare Limited, the PIL within the pack needs to be removed and replaced with the corrected PIL
    • The correct PIL can also be downloaded from the eMC website

 

Further information can be found on the MHRA section on the GOV.UK website.

Produced by the NPA Pharmacy Services team February 2019.