Class 2 Medicines recall: Zantac 75 Relief Tablets, Zantac 75 Tablets, Galpharm Indigestion Relief 75mg Tablets, Boots Heartburn & Indigestion Relief 75mg Tablets, Kirkland Indigestion Relief 75mg Tablets, Morrisons Indigestion & Heartburn Relief 75mg Tablets, Boots Heartburn & Indigestion Relief 75mg Tablets (EL (19)A/30)

Omega Pharma Limited and Galpharm International Limited are recalling unexpired stock from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity.

Product information

PL number

  • Zantac 75 Relief Tablets: PL 02855/0081

  • Zantac 75 Tablets: PL 02855/0082

  • Galpharm Indigestion Relief 75mg Tablets: PL 16028/0122

  • Boots Heartburn & Indigestion Relief 75mg Tablets: PL 16028/0122

  • Kirkland Indigestion Relief 75mg Tablets: PL16028/0122

  • Morrisons Indigestion & Heartburn Relief 75mg Tablets: PL 16028/0122

  • Boots Heartburn & Indigestion Relief 75mg Tablets: PL 16028/0123

MDR Number

MDR 56-09/19

Company name

  • Omega Pharma Limited trading as Perrigo

  • Galpharm International Limited (part of the Perrigo Group)

Product description

Omega Pharma Limited trading as Perrigo

Product PL Number
Zantac 75 Relief Tablets 02855/0081
Zantac 75 Tablets 02855/0082

Galpharm International Limited (part of the Perrigo Group)

Product (GSL) PL Number
Galpharm Indigestion Relief 75mgTablets 16028/0122
Boots Heartburn & Indigestion Relief 75mg Tablets 16028/0122
Kirkland Indigestion Relief 75mg Tablets 16028/0122
Morrisons Indigestion & Heartburn Relief 75mg Tablets 16028/0122
Product (P) PL Number
Boots Heartburn & Indigestion Relief 75mg Tablets 16028/0123

Generic Name: Ranitidine

Brief description of the problem

Omega Pharma Limited and Galpharm International Limited are recalling all unexpired stock 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

  • 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.

Further Information

For stock control enquiries please contact Perrigo Customer Service team on +44 (0)1226 704711 or customerservice@perrigouk.com

For medical information enquiries please contact Perrigo Pharmacovigilance Department on +44 (0)203 598 9603 or UKLOCustomerService@perrigo.com

Omega Pharma Ltd (Zantac Products):

Please contact the Alloga UK Credits team via telephone on 01773 515172 or via email AllogaUK.Credit.Claims@Alloga.co.uk to arrange collection of any stock subject to this recall.

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.

Document

Class 2 Medicines recall: Zantac 75 Relief Tablets, Zantac 75 Tablets, Galpharm Indigestion Relief 75mg Tablets, Boots Heartburn & Indigestion Relief 75mg Tablets, Kirkland Indigestion Relief 75mg Tablets, Morrisons Indigestion & Heartburn Relief 75mg Tablets, Boots Heartburn & Indigestion Relief 75mg Tablets (EL (19)A/30)

Published 25 October 2019