GovWire

MDR Number

MDR 130-10/22

Company name

Medreich PLC

Product description

Mebeverine hydrochloride 135mg Film-coated Tablets PL 21880/0247

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 suppliers approved process.

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 020 8831 1580, 020 8831 1511 or 020 8831 1509

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

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone: +44 (0)20 3080 6574

Email: dmrc@mhra.gov.uk

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