Class 2 pharmacy level medicines recall – Action within 48 hours – Ranitidine effervescent tablets 150mg and 300mg

17 Oct 2019

A Class 2 pharmacy level medicines recall has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for Ranitidine effervescent tablets 150mg and 300mg (Teva UK Limited t/a ratiopharm GmbH) - actions to take for pharmacy teams dispensing/supplying these products

Ref: EL (19)A/27

17 October 2019

Ranitidine effervescent tablets 150mg
Ranitidine effervescent tablets 300mg
(Manufactured by Teva UK limited t/a ratiopharm GmbH)

PL 15773/066

PL 15773/067

A Class 2 medicines recall has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for several batches of ranitidine effervescent tablets 150mg and 300mg – this is a pharmacy level recall alert which requires action within 48 hours of the alert being issued on 17 October 2019:

Ranitidine effervescent tablets 150mg   (PL 15773/066)

Batch Number Expiry Date Pack Size First Distributed
17007672 30/04/2020 1 x 60 tablets 01 September 2017
17011546 30/06/2020 1 x 60 tablets 19 December 2017
17017838 30/09/2020 1 x 60 tablets 28 March 2018
18001231 31/12/2020 1 x 60 tablets 15 August 2018
18006590 31/03/2021 1 x 60 tablets 20 November 2018
18006591 31/03/2021 1 x 60 tablets 03 December 2018
18010644 30/06/2021 1 x 60 tablets 06 November 2018
18010645 30/06/2021 1 x 60 tablets 05 June 2018

Ranitidine effervescent tablets 300mg   (PL 15773/067)

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

Teva UK Ltd is recalling all unexpired stock of the above preparations from pharmacies due to potential contamination of ranitidine with N-nitrosodimethylamine (NDMA) as an impurity — this is a precautionary measure as NDMA has genotoxic and carcinogenic potential. The MHRA’s press release provides further details about this drug alert.

Advice for healthcare professionals, including pharmacy teams

Pharmacists and pharmacy teams are required to:

  1. Stop supplying the affected products immediately
  2. Quarantine all remaining stock and return it to the supplier using their agreed process
  3. Provide the following advice to patients making enquiries about the issue:
    • Do not stop taking their medicines – stopping treatment can pose more of a health risk than the contaminant presents
    • Patients do not need to see their doctor until their next routine appointment/treatment review
    • Speak to their doctor if they have concerns

Teva can be contacted as below:

Produced by the NPA Pharmacy Services team October 2019.