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.