The Medicines and Health products Regulatory Agency (MHRA) has issued a class two medicines recall for mepacrine hydrochloride 100mg tablets with batch number 85641 of BCM Specials Limited.
The decision to recall the drug follows detection of foreign body particulates, including glass and rubber, in one of the containers of the Active Pharmaceutical Ingredient (API) used in the manufacture of mepacrine hydrochloride 100mg tablets.
“No foreign body particulates were identified during the manufacturing process, routine associated batch analysis or investigative analysis performed to date, however, because of the use of API from the affected container in the manufacture of batch 85641 the decision to recall all available stock from this batch has been made as a precautionary measure,” the drug manufacturer informed the MHRA.
Community pharmacists have been advised to contact patients who have been supplied mepacrine hydrochloride 100mg tablets from the affected batch and ask them to stop using tablets from this batch as soon as possible and return any unused medicine to pharmacy.
MHRA has also asked the pharmacy teams to immediately stop supplying the recalled product and remove it from the shelves.
All remaining stock should be returned to the supplier using your supplier’s approved process, MHRA has said.
