Class 2 Medicines recall: Ranitidine 75mg Tablets, (Various Liveries) (EL(19)A/37)

OTC Concepts Ltd, Relonchem Ltd, Noumed Life Sciences Ltd and Medreich Plc. are recalling stock from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity.

From:
Medicines and Healthcare products Regulatory Agency
Published
21 November 2019
Message type:
Medicines recall/notification
Medical specialty:
General practice and Pharmacy
Issued:
21 November 2019

Product information

PL number

OTC Concepts Limited

  • Ranitidine 75mg Tablets: PL 20338/0020

Relonchem Limited

  • Relonchem Ranitidine 75mg Tablets (6): PL 20395/0079

  • Relonchem Ranitidine 75mg Tablets (12): PL 20395/0079

  • Bells Healthcare Ranitidine 75mg Tablets (12): PL 20395/0079

  • Numark Ranitidine 75mg Film Coted Tablets (12): PL 20395/0079

  • Tesco Heartburn and Indigestion Relief 75mg Film Coated Tablets (12): PL 20395/0079

Noumed Life Sciences Limited

  • Noumed Indigestion Relief 75mg Film-Coated Tablets: PL 44041/0027

  • Gavilast Heartburn and Indigestion 75mg Film-Coated Tablets: PL 44041/0028

  • Ranitidine 75mg Film-Coated Tablets: PL 44041/0028

Medreich PLC

  • ASDA Ranitidine 75 mg Tablets (12): PL 21880/0022

  • Peach Ethical Indigestion Relief Ranitidine 75mg Film Coated Tablets (12): PL 21880/0022

  • Sainsbury’s Indigestion Relief Tablets (12): PL 21880/0022

  • Tesco Indigestion Relief Ranitidine 75mg film-coated tablets: PL 21880/0022

MDR Number

MDR 56-09/19

Company name

  • OTC Concepts Limited
  • Relonchem Limited
  • Noumed Life Sciences Limited
  • Medreich PLC

Product description

All unexpired batches of:

OTC Concepts Limited

  • Ranitidine 75mg Tablets: PL 20338/0020

Relonchem Limited

  • Relonchem Ranitidine 75mg Tablets (6): PL 20395/0079
  • Relonchem Ranitidine 75mg Tablets (12): PL 20395/0079
  • Bells Healthcare Ranitidine 75mg Tablets (12): PL 20395/0079
  • Numark Ranitidine 75mg Film Coted Tablets (12): PL 20395/0079
  • Tesco Heartburn and Indigestion Relief 75mg Film Coated Tablets (12): PL 20395/0079

Noumed Life Sciences Limited

  • Noumed Indigestion Relief 75mg Film-Coated Tablets: PL 44041/0027
  • Gavilast Heartburn and Indigestion 75mg Film-Coated Tablets: PL 44041/0028
  • Ranitidine 75mg Film-Coated Tablets: PL 44041/0028

Specific batches of:

Medreich PLC

  • ASDA Ranitidine 75 mg Tablets (12): PL 21880/0022
    • Batch Number: 370190
    • Expiry Date: 31/01/2020
    • Pack Size: 1 x 12
    • First Distributed: August 2017

Peach Ethical Indigestion Relief Ranitidine 75mg Film Coated Tablets (12): PL 21880/0022

  • Batch Number: 370049
  • Expiry Date: 31/12/2019
  • Pack Size: 1 x 12
  • First Distributed: October 2017

Sainsbury’s Indigestion Relief Tablets (12): PL 21880/0022

  • Batch Numbers: 370065, 370066
  • Expiry Date: 31/12/2019
  • Pack Size: 1 x 12
  • First Distributed: May 2017

Tesco Indigestion Relief Ranitidine 75mg film-coated tablets: PL 21880/0022

Batch Number Expiry Date Pack Size First Distributed
370050 31/12/2019 1 x 12 March 2017
370051 31/12/2019 1 x 12 March 2017
370052 31/12/2019 1 x 12 April 2017
370064 31/12/2019 1 x 12 May 2017

Brief description of the problem

Generic Name: Ranitidine

OTC Concepts Ltd, Relconchem Ltd and Noumed Life Sciences Ltd are recalling all unexpired batches of the above products from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

Medreich Plc are recalling specific batches of the above products from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

Advice for healthcare professionals and retail stores

  • Stop supplying the above products immediately and remove from the shelves within your store. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

  • If you receive queries about this issue from patients, advise them to contact their GP, pharmacist or healthcare professional to review ongoing treatment.

This is an on-going issue and the MHRA is actively involved with the European Medicines Agency and with other medicines regulators to determine any possible impact. An investigation into other potentially impacted products is continuing and further updates will be provided as the investigation progresses.

Company contacts for further information

OTC Concepts Limited

Relonchem Limited

  • For stock control enquiries please contact Relonchem Customer Service team on +44 (0) 151 422 1200 or sales@relonchem.com

  • For medical information enquiries please contact Relonchem Pharmacovigilance Department on +44 (0) 151 556 1857 or medicalinformation@relonchem.com

Noumed Life Sciences Limited

  • For stock control enquiries please contact Noumed Life Sciences Limited Customer Service team on +44 (0) 2033998900 or nicole.mascowe@noumed.co.uk

  • For medical information enquiries please contact Noumed Life Sciences Limited Pharmacovigilance Department on Tel +44 (0) 2033998960 or akhtarhms@skayedzan.co.uk

Medreich PLC

  • For stock control enquiries please contact Medreich Plc. Customer Service team on +44 (0) 20 8831 1580 or cs_team@medreich.co.uk

  • For medical information enquiries please contact Medreich Plc. Pharmacovigilance Department on +44 (0) 20 8831 1580 or qagroup@medreich.co.uk

Recipients should bring it to the attention of relevant contacts by copy of this letter.

NHS Regional teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.

Download the document

EL(19)A37

Updates to this page

Published 21 November 2019
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