Class 2 Medicines recall: Ranitidine Oral Solution 30mg/Ml (Creo Pharma Limited) and Ranitidine 150mg Tablets (Tillomed Laboratories Limited)

Class 2 Medicines recall: Ranitidine Oral Solution 30mg/Ml (Creo Pharma Limited) and Ranitidine 150mg Tablets (Tillomed Laboratories Limited)

November 19, 2019

Drug alert number: EL (19)A/36

Date issued: 19 November 2019

Creo Pharma Limited and Tillomed Laboratories Limited are recalling all unexpired stock of the ranitidine Oral Solution 30mg/Ml and ranitidine 150mg Tablets listed below from pharmacies as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

Creo Pharma Limited (Zentiva Pharma UK Ltd)

Product PL Number
Ranitidine Oral Solution 30mg/ml 31862/0023

Tillomed Laboratories Limited

Product  PL Number
Ranitidine 150mg Tablets 11311/0138

 

Advice for healthcare professionals and retail stores
• Stop supplying the above products immediately. 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 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.

View the full Drug Alert here.

Creo Pharma Limited:

For stock control enquiries contact Zentiva Customer Service team: 0844 8793 188 or GFD-CUSTOMERSERVICES@zentiva.com
For medical information contact Zentiva medical information team: 0800 090 2408 or UKMedInfo@zentiva.com

Tillomed Laboratories Limited:

For enquiries please email Tillomed on qa@tillomed.co.uk.

All stock should be returned to following address:
Mawdsley Brooks
Redhouse
Rockingham Way
Adwick-le-Street
Doncaster, DN6 7FB

 



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