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:
- Stop supplying the affected products immediately
- Quarantine all remaining stock and return it to the supplier using their agreed process
- 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.