MHRA: Stop supplying some mebeverine hydrochloride tablets ‘immediately’
The MHRA has asked pharmacies to stop the supply of a specific batch of mebeverine hydrochloride 135mg film-coated tablets “immediately”, after the product failed to meet its acceptance criteria during routine testing.
Manufacturer Medreich PLC UK is recalling a batch of mebeverine hydrochloride 135mg film-coated tablets, and the Medicines and Healthcare products Regulatory Agency (MHRA) asked pharmacies this morning (October 27) to “quarantine all remaining stock and return it to your supplier”.
While the affected batch – B11539 – is only being recalled “as a precautionary measure”, it was found to produce “out-of-specification results for tablet dissolution” during routine testing, the medicines watchdog warned.
However, the marketing authorisation holder “has not received any reports of adverse reactions related to this issue”, it added.
“No further action required by patients”
Patients should be advised to continue taking the tablets as prescribed by their relevant healthcare professional, the MHRA urged.
No further action is required by patients “as this is a pharmacy and wholesaler level recall”, the regulator added.
However, if patients do experience “adverse reactions or insufficient control of symptoms”, they should seek medical attention, the MHRA stressed.
Side effects to any medication can be reported to the MHRA’s Yellow Card scheme, it added.
