Class 2 Medicines Recall: Ranitidine Oral Solution 30mg/ml, PL 31862/0023, Ranitidine 150mg Tablets, PL 11311/0138 (EL(19)A/36)
Creo Pharma Limited and Tillomed Laboratories Limited are recalling all unexpired stock of the products listed in this alert.
Product information
PL number
Creo Pharma Limited (Zentiva Pharma UK Ltd) - Ranitidine Oral Solution 30mg/ml: PL 31862/0023
Tillomed Laboratories Limited - Ranitidine 150mg Tablets: PL 11311/0138
MDR Number
MDR 56-09/19
Company name
Creo Pharma Limited (Zentiva Pharma UK Ltd) - Ranitidine Oral Solution 30mg/ml: PL 31862/0023
Tillomed Laboratories Limited - Ranitidine 150mg Tablets: PL 11311/0138
Product description
Creo Pharma Limited (Zentiva Pharma UK Ltd)
- Product: Ranitidine Oral Solution 30mg/ml
- PL Number: PL 31862/0023
Tillomed Laboratories Limited
- Product: Ranitidine 150mg Tablets
- PL Number: PL 11311/0138
Brief description of the problem
Creo Pharma Limited and Tillomed Laboratories Limited are 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
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Stop supplying the above products immediately. 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 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.
Company contacts for further information
Creo Pharma Limited
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For stock control enquiries please contact Zentiva customer service team on +44 (0) 844 8793 188 or GFD-CUSTOMERSERVICES@zentiva.com
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For medical information enquiries please contact Zentiva medical information team on +44 (0) 800 090 2408 or UKMedInfo@zentiva.com
Tillomed Laboratories Limited
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For enquiries please email Tillomed on qa@tillomed.co.uk
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All stock should be returned to following address:
Mawdsley Brooks
Redhouse
Rockingham Way
Adwick-le-Street
Doncaster, DN6 7FB
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