An antidepressant has been recalled as a “precautionary measure” after an “error at the manufacturing site” led to a different drug being incorrectly packaged in one of its cartons.
The Medicines and Healthcare products Regulatory Agency (MHRA) said on April 28 that the recall of a batch of sertraline 100mg film-coated tablets follows a patient complaint to the manufacturer about “the adverse event of headache”.
It was discovered that the pack of sertraline also contained a blister strip of citalopram 40mg film-coated tablets “inside the sealed carton”, the regulator added.
Read more: Patient complaint forces blood pressure medication recall
Manufacturer Amarox Limited issued the recall for batch number V2500425 of the medicine, which was first distributed on November 28 to patients, pharmacies and wholesalers.
Sertraline and citalopram are both selective serotonin reuptake inhibitors used to treat depression, anxiety disorders and other mental health conditions.
The MHRA said both medications were manufactured at the same site and that the error “appears to have occurred during secondary packaging of the blister strips”.
“Already consumed”
The MHRA told healthcare professionals to stop supplying the affected batch “immediately”, quarantine all remaining stock and return it to their supplier.
And patients who believe they have taken citalopram 40mg tablets “by mistake or are experiencing side effects” have been advised to seek medical advice “immediately”.
The regulator also told pharmacists involved in dispensing to “identify and contact any patients” who have been supplied the affected medication and ask them to return it.
Read more: Antidepressants: MHRA to ‘strengthen’ leaflet suicide warning
But as the “majority” of the packs were distributed in 2025, it is “expected” that many of them will have been “dispensed to patients and consumed”, it added.
The MHRA also said that pharmacists should contact any affected patients’ GP or the healthcare professional responsible for their care to “discuss treatment review and whether a new prescription is required for ongoing resupply”.
Heightened side effects
MHRA chief safety officer Dr Alison Cave said patients who have “accidentally taken citalopram” instead of or with sertraline “may experience some heightened serotonergic side effects”.
“These can include nausea, headaches, sleep changes and mild anxiety,” she added.
Read more: Antidepressant SSP issued amid ‘large number’ of invalid claims
It follows a blood pressure medication being recalled last week after a patient complained about receiving a lower dose.
The MHRA said the precautionary recall of Ramipril 10mg capsules was issued by Crescent Pharma Limited over a “potential manufacturing error”.
