Class 2 Medicines recall: Ranitidine 150mg Film-Coated Tablets, PL 20075/0063, Ranitidine 300mg Film-Coated Tablets, PL 20075/0064 (EL(19)A/40)
Read the official alert on GOV.UK — MedRegWatch re-presents it; GOV.UK is the authoritative source.
| Class | Class 2 |
|---|---|
| Type | Medicines recall/notification |
| Issued | 5 Dec 2019 |
| Reference | EL (19)A/40 |
| Company | Ranitidine 150mg Film-Coated Tablets |
| Product licences | PL 20075/0063 · PL 20075/0064 |
Product information
PL number
| Product | PL Number |
|---|---|
| Ranitidine 150mg Film-Coated Tablets | PL 20075/0063 |
| Ranitidine 300mg Film-Coated Tablets | PL 20075/0064 |
Company name
Accord Healthcare
Product description
Ranitidine 150mg Film-Coated Tablets
Ranitidine 300mg Film-Coated Tablets
Brief description of the problem
Accord Healthcare are recalling all unexpired stock of the Ranitidine 150mg Film-Coated Tablets and Ranitidine 300mg Film-Coated Tablets products from pharmacies and wholesalers 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 wholesalers
-
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.
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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
For stock control enquiries please contact Accords Customer Service team on 0800 373573
For medical information enquiries please contact Accords Pharmacovigilance Department on 01271 385257 or medinfo@accord-healthcare.com.
Recipients should bring it to the attention of relevant contacts,
NHS Regional teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.