National Patient Safety Alert: Class 1 Medicines Recall for Co-codamol 30/500 effervescent tablets (Zentiva)

National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Co-codamol 30/500 Effervescent Tablets (Zentiva Pharma UK Ltd) Co-codamol 30/500 Effervescent Tablets PL 17780/0046

NatPSA/2021/004/MHRA

Date issued: 16 June 2021

Zentiva Pharma UK Limited is recalling the below batch of Co-codamol 30/500 Effervescent Tablets as a precautionary measure due to an issue with the homogeneity of the batch. This issue means that there is the potential for some tablets to have too little active ingredients (codeine phosphate and paracetamol) in them and some tablets to contain too much active ingredients. The current investigation has highlighted that tablets have been identified where the content of both codeine and paracetamol is less than the label claim.

Advice for healthcare professionals (actions to complete by 21 June 2021)

• Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
• Contact all patients who have been dispensed the impacted batch and ask them to urgently return this stock to the pharmacy for replacement.
• See the alert for a suggested patient letter to assist with contacting patients. However, local practices may differ. The most important thing is that affected patients are contacted as soon as possible.
• Patients should be advised to report any side effects to their healthcare professional and via the MHRA Yellow Card Scheme

Further information

Full drug alert can be viewed here.

National Patient Safety Alert can be viewed here

Company contacts for further information

For more information or medical information queries please contact 0800 090 2408 or email UKMedInfo@zentiva.com

For supply queries, please contact 0844 8793188 or email gfd-customerservices@zentiva.com

Please contact claims@zentiva.com to arrange return and replacement of affected packs in your possession.