Batch Number 1K10121 has been found to potentially have the wrong amount of active ingredients
People who use Co-codamol 30/500 Effervescent Tablets, widely used for pain relief, are today being asked to check the batch number on the labels of packs to ensure they are not one of 4,464 packs which are being recalled due to safety concerns. This advice follows a Class 1 National Patient Safety Alert that has been issued.
Manufacturer, Zentiva Pharma UK Limited informed the MHRA that packs of Co-codamol 30/500 Effervescent Tablets with Batch Number 1K10121 have been found to potentially have too little of the active ingredients (codeine phosphate and paracetamol) in them which may mean that the medicine does not work as it should do, and some tablets may also contain too much of the active ingredients and therefore potentially result in overdose.
General symptoms of opioid toxicity include coma, confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and can be fatal.
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, renal failure may progress to encephalopathy, gastrointestinal bleeding, coma and death.
If patients have packs which match the label details below, they are advised to return them to their pharmacy for a replacement immediately. Patients should not use any tablets from these packs.
We are advising healthcare professionals to stop supplying the affected batch immediately, quarantine all remaining stock and return it to their supplier or the Marketing Authorisation Holder Zentiva Pharma UK Ltd.
MHRA Chief Quality and Access officer, Dr Samantha Atkinson, said:
The batch number details are below:
Notes to Editors: