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UK issues recall of antidepressant tablets after packaging error

The action follows a patient complaint after a sealed carton of sertraline was found to contain one blister strip of Citalopram 40mg tablets.

​Amarox

Amarox Limited said it is recalling one batch of Sertraline 100mg film-coated tablets as a precaution.

MHRA

A BATCH of antidepressant medication in the UK has been recalled after a packaging error led to the wrong tablets being included in some packs.

Amarox Limited said it is recalling one batch of Sertraline 100mg film-coated tablets as a precaution.


The action follows a patient complaint after a sealed carton of sertraline was found to contain one blister strip of Citalopram 40mg tablets.

Sertraline and citalopram are both selective serotonin reuptake inhibitors used to treat depression, anxiety disorders and related conditions by increasing serotonin levels in the brain. Both medicines are produced by the same manufacturer at the same site. The issue has been linked to an error during the packaging of blister strips into cartons.

Patients in the UK who may have taken Citalopram 40mg tablets by mistake or are experiencing side effects have been advised to seek medical advice.

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.”

Pharmacists and other healthcare professionals have been asked to contact affected patients and return any remaining stock. The MHRA has also advised stopping supply of the affected batch and returning it to suppliers. Suspected adverse reactions should be reported through the MHRA Yellow Card scheme.

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