Teva UK Recall Unexpired Stock of Ranitidine Effervescent Tablets

| By | Drug Recall, TEVA
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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.

SOURCE: gov.uk
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