Class 2 Medicines Recall: Medley Pharma Limited, Ranitidine 150mg Tablets BP, PL 43870/0026, Ranitidine 300mg Tablets BP, PL 43870/0027 (EL(19)A/41)
Medley Pharma Limited is recalling all unexpired stock of the below products from pharmacies and retail stores as a precautionary measure.
Product information
PL number
MDR Number
MDR 56-09/19
| Product | PL Number |
|---|---|
| Ranitidine 150mg Tablets BP | 43870/0026 |
| Ranitidine 300mg Tablets BP | 43870/0027 |
Company name
Medley Pharma Limited
Product description
Ranitidine 150mg Tablets BP
Ranitidine 300mg Tablets BP
Brief description of the problem
Medley Pharma Limited is recalling all unexpired stock 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 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 Customer Service team on 01515214527 or sales@medleypharma.co.uk
For medical information enquiries please contact Jo Bunyan Pharmacovigilance Department on 07946548344 or jo@callisto-consulting.co.uk
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.
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