Class 2 pharmacy level medicines recall – Action within 48 hours – ranitidine products

Class 2 pharmacy level medicines recall – Action within 48 hours – ranitidine products manufactured by Creo Pharma Limited (Zentiva Pharma UK Ltd) and Tillomed Laboratories Limited

DRUG ALERT

Class 2 medicines recall – Action within 48 hours – Ranitidine products
(Creo Pharma Limited (Zentiva Pharma UK Ltd) and Tillomed Laboratories Limited)

Ref: EL (19)A/36

19 November 2019

Ranitidine oral solution 30mg/1ml – PL 31862/0023
(Manufactured by Creo Pharma Limited (Zentiva Pharma UK Ltd)

Ranitidine tablets 150mg – PL 11311/0138
(Manufactured by Tillomed Laboratories Limited)

A Class 2 medicines recall has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for two ranitidine products. – this is a pharmacy level recall alert which requires action within 48 hours of the alert being issued on 19 November 2019:

Creo Pharma Limited (Zentiva Pharma UK Ltd) and Tillomed Laboratories Limited are recalling all unexpired stock of the above preparations from pharmacies due to potential contamination of ranitidine with N-nitrosodimethylamine (NDMA) as an impurity — this is a precautionary measure as NDMA has genotoxic and carcinogenic potential.

Advice for healthcare professionals, including pharmacy teams

Pharmacists and pharmacy teams are required to:

1. Stop supplying the affected products immediately
2. Quarantine all remaining stock and return it to the supplier using their agreed process
3. Provide the following advice to patients making enquiries about the issue:
   • Do not stop taking their medicines – stopping treatment can pose more of a health risk than the contaminant presents
   • Patients do not need to see their doctor until their next routine appointment/treatment review
   • Speak to their doctor if they have concerns

Creo Pharma Limited (Zentiva Pharma UK Ltd) can be contacted as below:

• Stock control enquiries – contact the Customer Services team on 0844 8793 188 or
  GFD-CUSTOMERSERVICES@zentiva.com
• Medical information enquiries — contact the Medical Information team on 800 090 2408 or UKMedInfo@zentiva.com

Tillomed Laboratories Limited can be contacted as below:

• For all enquires email qa@tillomed.co.uk
• Stock should be returned to following address:
  Mawdsley Brooks
  Redhouse
  Rockingham Way
  Adwick-le-Street
  Doncaster
  DN6 7FB

Produced by the NPA Pharmacy Services team November 2019.