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 [email protected].
For medical information enquiries please contact Teva UK Medical Information Department on 0207 540 7337 or [email protected].
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