Sertraline recall issued April 28 over Citalopram packaging error | UK | News

A precautionary recall of a widely used antidepressant has been announced today, April 28, following a manufacturing error. Amarox Limited is withdrawing one batch of Sertraline 100mg film-coated tablets as a precautionary measure following a production error that resulted in two antidepressant medicines being incorrectly packaged.

The Medicines and Healthcare products Regulatory Agency (MHRA) has urged healthcare professionals to cease supplying the affected batch of Sertraline 100mg and return all remaining stock to their suppliers. The recall was triggered by a patient complaint that revealed a pack of Sertraline 100mg film-coated tablets contained one blister strip of Citalopram 40mg film-coated tablets inside the sealed carton, reports the Mirror.

Sertraline and citalopram are both selective serotonin reuptake inhibitors (SSRIs). They are used to treat depression, anxiety disorders, and related mental health conditions by boosting brain serotonin.

Both SSRI medications are manufactured by the same company at the same facility, and the mistake is believed to have occurred during secondary packaging of the blister strips into cartons. Any patients who suspect they may have inadvertently taken Citalopram 40mg tablets or are experiencing adverse side effects are strongly urged to seek medical attention without delay.

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.

“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.

“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.”

All potentially affected people should be notified. A statement on the official Gov.uk website states: “Pharmacists and other healthcare professionals involved in dispensing should identify and contact any patients who may have received the impacted product and request that any remaining medicine be returned.”

It further adds: “If any patients are identified with this product, pharmacists and other healthcare professionals involved in dispensing should contact the patients’ GP or the clinician responsible for their care to discuss a treatment review and whether a new prescription is required for ongoing resupply.”

Those affected by the recall may require monitoring by their GP or another medical professional. This is especially crucial for patients who are over 65 or under 18, suffer from heart or liver conditions, or have been informed that their body metabolises certain medications differently.

Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme. The MHRA has advised healthcare professionals to stop supplying the affected batch and return all remaining stock to their suppliers.

Healthcare professionals should be advised to inform patients who may have inadvertently ingested citalopram tablets in place of or in addition to their prescribed sertraline that they may experience increased serotonergic effects.

Gov.uk added: “The reported adverse event in this case was a headache, which resolved on discontinuation; however, in susceptible individuals, concurrent exposure to two SSRIs may carry a risk of more pronounced serotonergic effects. The risk is however higher in patients with pre-existing cardiac conditions, those aged over 65 years, or those taking concomitant serotonergic or QT prolonging medication.”