Drug Alert: Mepacrine hydrochloride tablets 100mg (unlicensed) (02/07/2020)

2nd July 2020

BCM Specials Limited has informed the MHRA that foreign body particulates (including glass and rubber) have been found in a container of the Active Pharmaceutical Ingredient (API) which is used to manufacture mepacrine hydrochloride tablets 100mg. Small quantities of the affected API has been used to manufacture the affected batch below.

No foreign body particulates were found either during the manufacturing process routine associated batch analysis or investigative analysis performed to date, however a decision was taken to recall all stock which was made with the affected API.

Batch number Expiry Pack size First distribution date
85641 January 2022 50 tablets October 2019

Key points for pharmacy teams

  • Contact any patient that has been dispensed the affected batch of mepacrine hydrochloride tablets 100mg.
  • Advise the patients to stop using the affected batch as soon as they can and return any unused medicine to the pharmacy.
  • Pharmacy teams should not dispense the affected batch. Any batches in stock should be quarantined and returned to the supplier.
  • For more information / medical information, contact regulatory.bcm@fareva.com or telephone 0115 968 6075.

 Further details:

Please contact the Pharmacy Services team for further advice and support: