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Batches of a medicine that is commonly prescribed to people who have had a heart attack or stroke have been recalled by its manufacturer because of a formulation error.

Xeal Pharma notified the Medicines and Healthcare products Regulatory Agency (MHRA) that all strengths of its Clopidogrel Oral Suspension and Clopidogrel Oral Solution products contain less than the required amount of clopidogrel, an antiplatelet medicine that helps stop blood clots.

“Due to a formulation error, the impacted batches contain 76 per cent of the required amount of clopidogrel,” the MHRA said yesterday. “All batches produced prior to this notification are affected.”

The medicine is also prescribed for unstable chest pain, atrial fibrillation and following a stent procedure.

The MHRA urged healthcare professionals to stop supplying the affected batches immediately, quarantine all remaining stock and return it to their supplier.

The regulator said pharmacists “should identify and immediately contact all patients who have been dispensed these batches and ask them to confirm if they have remaining stock within their possession”.

The MHRA also said all patients dispensed the product from July 20 this year should be contacted and told it contains a lower dose than prescribed “if batch traceability information is not available”.

“Patients and carers should be reminded that suddenly stopping this medicine may cause serious thrombotic events,” the MHRA added.

“If the pharmacist identifies any patients with an impacted product, they should contact the patient’s GP or prescriber and discuss ongoing treatment for the patient. As patients may require monitoring, other clinicians and healthcare professionals may need to be involved.

“Prescribers, clinicians and other healthcare professionals involved in the prescribing/monitoring of patients who are using Clopidogrel Oral Solution or Suspension should contact their patients and/or carers directly to ensure their treatment is reviewed.”

The MHRA said it has received no reports of patient harm and the recall was “being undertaken out of an abundance of caution”.

The regulator warned patients not to stop taking clopidogrel without medical advice as doing so could cause “serious thrombotic events”.

“Xeal Pharma have confirmed that all future stock will be manufactured with the correct strength and calculations applied,” the MHRA said, adding patients with affected batches may need “a dose correction, alternative licensed formulations or a different treatment option”.