Recall of Co-codamol 30/500 Effervescent Tablets, Batch 1K10121, Zentiva Pharma UK Ltd due to precautionary risk of causing overdose
Zentiva Pharma UK Limited have notified the MHRA of an issue related to the homogeneity of a batch of Co-codamol 30/500 Effervescent Tablets that could result in a potential underdose and lack of efficacy or an overdose.
Active Pharmaceutical Ingredients:
- · 30mg codeine phosphate hemihydrate
- · 500mg paracetamol
The specific batch is being recalled as a precautionary measure due to the outcome of an ongoing investigation by the Marketing Authorisation Holder (MAH) which has concluded 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.
This alert is for action by: primary and secondary care, specifically those involved in pharmacy services, including dispensing general practices.
|Originator:||National Patient Safety Alert – MHRA|
|Issue date:||16-Jun-2021 11:16:56|
|This alert has been issued to:|