Class 2 Medicines recall: Ranitidine 75mg Tablets, (Various Liveries) (EL(19)A/37)
OTC Concepts Ltd, Relonchem Ltd, Noumed Life Sciences Ltd and Medreich Plc. are recalling stock from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity.
Product information
PL number
OTC Concepts Limited
- Ranitidine 75mg Tablets: PL 20338/0020
Relonchem Limited
-
Relonchem Ranitidine 75mg Tablets (6): PL 20395/0079
-
Relonchem Ranitidine 75mg Tablets (12): PL 20395/0079
-
Bells Healthcare Ranitidine 75mg Tablets (12): PL 20395/0079
-
Numark Ranitidine 75mg Film Coted Tablets (12): PL 20395/0079
-
Tesco Heartburn and Indigestion Relief 75mg Film Coated Tablets (12): PL 20395/0079
Noumed Life Sciences Limited
-
Noumed Indigestion Relief 75mg Film-Coated Tablets: PL 44041/0027
-
Gavilast Heartburn and Indigestion 75mg Film-Coated Tablets: PL 44041/0028
-
Ranitidine 75mg Film-Coated Tablets: PL 44041/0028
Medreich PLC
-
ASDA Ranitidine 75 mg Tablets (12): PL 21880/0022
-
Peach Ethical Indigestion Relief Ranitidine 75mg Film Coated Tablets (12): PL 21880/0022
-
Sainsbury’s Indigestion Relief Tablets (12): PL 21880/0022
-
Tesco Indigestion Relief Ranitidine 75mg film-coated tablets: PL 21880/0022
MDR Number
MDR 56-09/19
Company name
- OTC Concepts Limited
- Relonchem Limited
- Noumed Life Sciences Limited
- Medreich PLC
Product description
All unexpired batches of:
OTC Concepts Limited
- Ranitidine 75mg Tablets: PL 20338/0020
Relonchem Limited
- Relonchem Ranitidine 75mg Tablets (6): PL 20395/0079
- Relonchem Ranitidine 75mg Tablets (12): PL 20395/0079
- Bells Healthcare Ranitidine 75mg Tablets (12): PL 20395/0079
- Numark Ranitidine 75mg Film Coted Tablets (12): PL 20395/0079
- Tesco Heartburn and Indigestion Relief 75mg Film Coated Tablets (12): PL 20395/0079
Noumed Life Sciences Limited
- Noumed Indigestion Relief 75mg Film-Coated Tablets: PL 44041/0027
- Gavilast Heartburn and Indigestion 75mg Film-Coated Tablets: PL 44041/0028
- Ranitidine 75mg Film-Coated Tablets: PL 44041/0028
Specific batches of:
Medreich PLC
- ASDA Ranitidine 75 mg Tablets (12): PL 21880/0022
- Batch Number: 370190
- Expiry Date: 31/01/2020
- Pack Size: 1 x 12
- First Distributed: August 2017
Peach Ethical Indigestion Relief Ranitidine 75mg Film Coated Tablets (12): PL 21880/0022
- Batch Number: 370049
- Expiry Date: 31/12/2019
- Pack Size: 1 x 12
- First Distributed: October 2017
Sainsbury’s Indigestion Relief Tablets (12): PL 21880/0022
- Batch Numbers: 370065, 370066
- Expiry Date: 31/12/2019
- Pack Size: 1 x 12
- First Distributed: May 2017
Tesco Indigestion Relief Ranitidine 75mg film-coated tablets: PL 21880/0022
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 370050 | 31/12/2019 | 1 x 12 | March 2017 |
| 370051 | 31/12/2019 | 1 x 12 | March 2017 |
| 370052 | 31/12/2019 | 1 x 12 | April 2017 |
| 370064 | 31/12/2019 | 1 x 12 | May 2017 |
Brief description of the problem
Generic Name: Ranitidine
OTC Concepts Ltd, Relconchem Ltd and Noumed Life Sciences Ltd are recalling all unexpired batches of the above products from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.
Medreich Plc are recalling specific batches of the above products from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.
Advice for healthcare professionals and retail stores
-
Stop supplying the above products immediately and remove from the shelves within your store. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
-
If you receive queries about this issue from patients, advise them to contact their GP, pharmacist or healthcare professional to review ongoing treatment.
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.
Company contacts for further information
OTC Concepts Limited
-
For stock control enquiries please contact Customer Service team on +44 (0) 1484 665733 or [email protected]
-
For medical information enquiries please contact Pharmacovigilance Department on +44 (0) 1525 292344 or [email protected]
Relonchem Limited
-
For stock control enquiries please contact Relonchem Customer Service team on +44 (0) 151 422 1200 or [email protected]
-
For medical information enquiries please contact Relonchem Pharmacovigilance Department on +44 (0) 151 556 1857 or [email protected]
Noumed Life Sciences Limited
-
For stock control enquiries please contact Noumed Life Sciences Limited Customer Service team on +44 (0) 2033998900 or [email protected]
-
For medical information enquiries please contact Noumed Life Sciences Limited Pharmacovigilance Department on Tel +44 (0) 2033998960 or [email protected]
Medreich PLC
-
For stock control enquiries please contact Medreich Plc. Customer Service team on +44 (0) 20 8831 1580 or [email protected]
-
For medical information enquiries please contact Medreich Plc. Pharmacovigilance Department on +44 (0) 20 8831 1580 or [email protected]
Recipients 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.
Download the document