Class 3 Medicines Recall: Medreich PLC, Mebeverine hydrochloride 135mg Film-coated tablets, EL (22)A/46
Medreich PLC UK is recalling a batch of Mebeverine hydrochloride 135mg film-coated tablets as a precautionary measure due to out of specification results for tablet dissolution during routine product release testing.
MDR Number
MDR 130-10/22
Company name
Medreich PLC
Product description
Mebeverine hydrochloride 135mg Film-coated Tablets PL 21880/0247
| Batch Number | Expiry Date | Pack Size | First Distributed |
| B11539 | Nov 2024 | 100 Tablets | 25 Aug 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.
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
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone: +44 (0)20 3080 6574
Email: dmrc@mhra.gov.uk
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