Class 3 Medicines Recall: Mebeverine hydrochloride 135mg Film-coated tablets

Drug alert number: EL (22) A/46

Date issued: 27th October 2022

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines recall for: Mebeverine hydrochloride 135mg Film-coated tablets (Medreich PLC) – PL 21880/0247

Batch Number Expiry Date Pack Size First Distributed
B11539 11/2024 100 tablets 25 August 2022

Active Pharmaceutical Ingredient: Mebeverine hydrochloride

Brief description of the problem

Medreich Plc UK is recalling the above batch as a precautionary measure due to out of specification results for tablet dissolution during routine product release testing.

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Full drug alert can be viewed here.

Advice for patients

  • No further action is required by patients as this is a Pharmacy and Wholesaler level recall.
  • Patients should continue to take medicines from this batch as prescribed by your healthcare professional.
  • The Marketing Authorisation Holder has not received any reports of adverse reactions related to this issue. However, patients who experience adverse reactions or insufficient control of symptoms should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Further Information

For more information or supply enquiries, please contact Medreich PLC at cs_team@medreich.co.uk or by phone at 0208 831 1580, 0208 831 1511 or 0208 831 1509
For medical information queries, please contact pharmacovigilance@medreich.com