class 3

Class 3 Medicines Recall: Medreich PLC, Mebeverine hydrochloride 135mg Film-coated tablets, EL (22)A/46

MDR Number: MDR 130-10/22

Company name: Medreich PLC

Product description and details of affected batches:

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.

Batch number

Expiry date

Pack size

First distributed

B11539

Nov 2024

100 Tablets

 

25 Aug 2022

 

Active Pharmaceutical Ingredient: Mebeverine hydrochloride

Advice to Healthcare Professionals:

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

Advice to 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.

Company contacts for further information:

For medical information enquiries, please contact For more information or supply enquiries, please contact Medreich PLC at cs_team@medreich.co.uk or by phone at 020 8831 1580, 020 8831 1511 or 020 8831 1509

For Medical Information enquiries, please contact pharmacovigilance@medreich.com

To access the full recall: Class 3 Medicines Recall: Medreich PLC, Mebeverine hydrochloride 135mg Film-coated tablets, EL (22)A/46