Class 2 Medicines recall: Ranitidine 75mg Tablets (Various Liveries)

Class 2 Medicines recall: Ranitidine 75mg Tablets (Various Liveries)

November 21, 2019

Drug alert number: EL (19)A/37

Date issued: 21 November 2019

OTC Concepts Ltd, Relconchem Ltd and Noumed Life Sciences Ltd are recalling all unexpired batches of the products listed below 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.

OTC Concepts Ltd

Product PL Number
Ranitidine 75mg Tablets 20338/0020

Relonchem Limited

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

Noumed Life Sciences Ltd

Product PL Number
Noumed Indigestion Relief 75mg Film-Coated Tablets 44041/0027
Gavilast Heartburn and Indigestion 75mg FilmCoated Tablets 44041/0028
Ranitidine 75mg Film-Coated Tablets 44041/0028

 

Medreich Plc are recalling specific batches of the products listed below 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

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

 

Peach Ethical Indigestion Relief Ranitidine 75mg Film Coated Tablets (12)
PL 21880/0022
Batch Number Expiry Date Pack Size First Distributed
370049 31/12/2019 1 x 12 October 2017

 

Sainsbury’s Indigestion Relief Tablets (12) PL 21880/0022
Batch Number Expiry Date Pack Size First Distributed
370065 31/12/2019 1 x 12 May 2017
370066 31/12/2019 1 x 12 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

Advice for healthcare professionals and retail stores
• Stop supplying the above products immediately and remove from shelves in 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.

View the full Drug Alert here.

Company contacts for further information

OTC Concepts Limited
• For stock control enquiries please contact Customer Service team on +44 (0) 1484 665733 or Warehouse@dalkeithlabs.co.uk
• For medical information enquiries please contact Pharmacovigilance Department on +44 (0) 1525 292344 or RanitidinePV@dalkeithlabs.co.uk

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



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