Sertraline batch recalled after pack found to contain wrong antidepressant drug
Patients prescribed sertraline have been told to check the batch number on their pack after the medicines regulator issued a recall.
The Medicines and Healthcare products Regulatory Agency, the MHRA, has recalled one batch of sertraline 100mg film-coated tablets after a manufacturing error meant some packs contained citalopram 40mg tablets instead.
The affected batch number is V2500425.
The batch number and expiry date are printed on the side of the outer packaging.
The recall, issued today, is a Class 2 medicines recall, meaning use of the affected product may cause temporary or medically reversible adverse health consequences.
It is being carried out as a precautionary measure by the manufacturer, Amarox Limited.
The error was identified after a patient complaint, with one pack of sertraline 100mg found to contain a sealed blister strip of citalopram 40mg inside the carton.
Sertraline and citalopram are both selective serotonin reuptake inhibitors, used to treat depression, anxiety and related conditions.
The MHRA said both medicines are produced by the same manufacturer at the same site, with the error appearing to have happened during the secondary packaging of blister strips into cartons.
Dr Alison Cave, MHRA Chief Safety Officer, said: “If you have been prescribed Sertraline 100mg tablets and have received batch number V2500425, please check the carton contains the right medication. You can find the batch number and expiry date printed on the side of the outer packaging.”
Dr Cave added: “If the blister strips inside the carton are labelled Citalopram 40mg, please contact your pharmacy as soon as possible. If they are labelled Sertraline 100mg, no further action is needed.”
She also said: “Patients who have accidentally taken citalopram instead of – or as well as – sertraline, may experience some heightened serotonergic side effects. These can include nausea, headache, sleep changes, and mild anxiety.”
Patients who believe they have taken citalopram by mistake or are experiencing side effects have been advised to seek medical advice.
The MHRA said pharmacists and other healthcare professionals dispensing the medicine should identify and contact any patients who may have received the affected pack.
Patients identified should be referred back to their GP or clinician to discuss treatment review and any new prescription required.
The regulator said monitoring may be needed, particularly for patients aged over 65 or under 18, those with cardiac or liver conditions, or those who have been told their bodies process certain medicines differently.
Healthcare professionals have been told to stop supplying the affected batch and return remaining stock to suppliers.
Suspected adverse reactions can be reported through the MHRA Yellow Card scheme.
Full details of the recall are available on the MHRA Class 2 recall notice.
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