Amarox Limited Issues Antidepressants Recall for Batch V2500425

Amarox Limited issued an antidepressants recall for Sertraline batch V2500425 after Citalopram 40mg was found inside a sealed carton.

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Precautionary recall of antidepressant medication due to manufacturing error
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has issued an for one batch of Sertraline 100mg film-coated tablets after a sealed carton was found to contain one blister strip of Citalopram 40mg. The affected batch is V2500425, and the told healthcare professionals to stop supplying it and return remaining stock to suppliers.

, the 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." She added: "You can find the batch number and expiry date printed on the side of the outer packaging."

V2500425 and the packaging error

The recall was issued as a precaution after a patient complaint led to the discovery of the wrong medicine inside a sealed carton. Amarox said the error appears to have happened during secondary packaging of the blister strips into the cartons, and both medicines were made by the same manufacturer at the same site.

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Sertraline and citalopram are both selective serotonin reuptake inhibitors used to treat depression, anxiety disorders and related mental health conditions. Sertraline prescriptions remain widespread: in 2019, GPs in England prescribed more than 16.7 million of them.

MHRA advice for pharmacies

The MHRA told healthcare professionals to stop supplying batch V2500425 and return all remaining stock to their suppliers. That instruction removes the affected batch from the supply chain while checks are carried out on the cartons already in circulation.

Dr Cave said: "If the blister strips inside the carton are labelled Citalopram 40mg, please contact your pharmacy as soon as possible." She also said: "If they are labelled Sertraline 100mg, no further action is needed."

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Advice for patients

Patients who believe they have already taken any Citalopram 40mg tablets by mistake, or who are experiencing side effects, are advised to seek medical advice immediately. Dr Cave said: "Patients who have accidentally taken citalopram instead of - or as well as - sertraline, may experience some heightened serotonergic side effects."

She said those effects can include nausea, headache, sleep changes and mild anxiety. For anyone with batch V2500425 at home, the check is simple: look at the side of the outer carton, then compare the blister strips before taking the tablets.

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