Class 2 Medicines recall: Ranitidine Effervescent Tablets 150mg, Ranitidine Effervescent Tablets 300mg (EL (19)A/27)

Teva UK Limited trading as ratiopharm GmbH is recalling all unexpired stock of Ranitidine Effervescent Tablets from pharmacies.

Product information

PL number

Ranitidine Effervescent Tablets 150mg PL 15773/066

Ranitidine Effervescent Tablets 300mg PL 15773/067

MDR Number

MDR 56-09/19

Company name

Teva UK Limited trading as ratiopharm GmbH

Product description

Ranitidine Effervescent Tablets 150mg (PL 15773/066)

Batch Number Expiry Date Pack Size First Distributed
17007672   30/04/2020   1 x 60   01/09/2017
17011546   30/06/2020   1 x 60   19/12/2017
17017838   30/09/2020   1 x 60   28/03/2018
18001231   31/12/2020   1 x 60   15/08/2018
18006590   31/03/2021   1 x 60   20/11/2018
18006591   31/03/2021   1 x 60   03/12/2018
18010644   30/06/2021   1 x 60   06/11/2018
18010645   30/06/2021   1 x 60   05/06/2019

Ranitidine Effervescent Tablets 300mg (PL 15773/067)

Batch Number Expiry Date Pack Size First Distributed
17001878   31/01/2020   1 x 30   27/06/2017
17011702   30/06/2020   1 x 30   09/07/2018

Generic Name: Ranitidine

Brief description of the problem

Teva UK Ltd is recalling all unexpired stock of the above products from pharmacies as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

Advice for healthcare professionals

  • Please stop supplying the above products immediately. Kindly quarantine all remaining stock without delay and return it to your supplier using your supplier’s approved process.

  • If you receive queries about this issue from patients, advise them not to stop taking their medication as the health risk of discontinuing the medicine is higher than the potential risk presented by the contaminant. A treatment review is not necessary until the next routine appointment.

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 Teva Customer Solutions team on 0800 590502 or customer.services@tevauk.com.

For medical information enquiries please contact Teva UK Medical Information Department on 0207 540 7337 or UK.Safety@tevauk.com.

Recipients of this Drug Alert 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

Drug alert: Ranitidine Effervescent Tablets

Updates to this page

Published 17 October 2019