More than 4,000 packs of widely used pain relief tablets have been recalled over safety concerns.
The Medicines and Healthcare products Regulatory Agency (MHRA) urged anyone who has a packet of Zentiva Pharma UK Ltd Co-codamol 30/500 Effervescent Tablets with batch number 1K10121 to return them to their pharmacy to be replaced.
It is usually prescribed ‘for the relief of severe pain’ which would not be helped by other analgesics like paracetamol or ibuprofen.
The MHRA said the batch was found to potentially have too little of the active ingredients, codeine phosphate and paracetamol, meaning the medicine would not work as it should. Some tablets may also have too much of the active ingredients, which could lead to overdose and dangerous side effects.
Opioid toxicity can cause comas, confusion, drowsiness, shallow breathing, nausea, vomiting, constipation and a lack of appetite, while in severe cases it can cause fatal circulatory and breathing disorders.
A paracetamol overdose may cause an unhealthy pale appearance, nausea, vomiting, anorexia and abdominal pain.
Severe cases can lead to gastrointestinal bleeding, coma and death.
There are 4,464 packs affected and each contains 100 tablets.
The MHRA issued a Class 1 National Patient Safety Alert on Wednesday, advising all healthcare professionals to ‘stop supplying the affected batch immediately, quarantine all remaining stock and return it to their supplier’.
MHRA chief quality and access officer Dr Samantha Atkinson said: ‘Patient safety is always our priority.
‘It is vitally important that people urgently check their packs of Zentiva Pharma UK Ltd Co-codamol 30/500 Effervescent Tablets and if the batch number corresponds to 1K10121, they should stop using them and return them to their pharmacy for a replacement immediately.
‘We are advising people not to take any tablets from these packs given the potential risks of doing so. Healthcare professionals should check their stocks and recall tablets from this batch urgently.
‘If anyone is concerned then please speak to your healthcare professional and report any adverse reactions via the Yellow Card Scheme.’
The Yellow Card scheme run by the MHRA collects information on safety concerns and suspected side effects from medicine and medical devices from professionals and members of the public.
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