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Zentiva co-codamol 30/500 effervescent tablets recall

Homogeneity concerns

June 17th 2021

Tagged: MHRA alert

By MHRA

Zentiva Pharma UK Limited is recalling one batch of  co-codamol 30/500 effervescent tablets due to risk of overdose.

The affected batch is

Batch NumberExpiry DatePack SizeFirst Distributed
1K10121December 2023100March 2021

This is a precautionary measure due to a problem with the homogeneity of the batch. This raises the potential for some tablets to have too little or too much of the active ingredients (codeine phosphate and paracetamol) and, the potential for suboptimal or overdosing.

Patients most at risk include:

  • elderly patients
  • patients with severe renal and hepatic impairment
  • in patients treated with paracetamol/codeine combination chronically and whose dosage is close to the maximum daily dose (eight tablets in 24 hours for adults and children above 16 years; four tablets in 24 hours for children 12-15 years).

By Monday 21 June, teams should quarantine all remaining stock and return it to the supplier using the approved process.

Teams should contact all patients who have been dispensed the impacted batch and ask them to urgently return this stock for replacement.

See a suggested patient letter to assist with contacting patients.

For more information or medical information queries please contact 0800 0902408 or email UKMedInfo@zentiva.com.

For supply queries, telephone: 0844 8793188 or email: gfd-customerservices@zentiva.com. Please contact claims@zentiva.com to arrange return and replacement of affected packs in your possession.