A batch of Sertraline 100mg antidepressants has been urgently recalled across the UK after a patient complaint revealed a packaging error. The Medicines and Healthcare products Regulatory Agency (MHRA) warned healthcare providers to stop dispensing the affected batch (V2500425) and return all stock due to one blister pack containing Citalopram 40mg tablets instead of Sertraline.
Packaging Error Exposed
The recall stems from a manufacturing mistake at Amarox Limited where blister packs of two different antidepressants were incorrectly placed in the same carton during secondary packaging. Sertraline and Citalopram, both SSRIs used to treat depression and anxiety, are produced at the same site, leading to the mix-up.
Patient Safety Alert
Dr Alison Cave, MHRA Chief Safety Officer, advised patients prescribed Sertraline 100mg to verify their medication and batch details immediately. She stated: “If the blister packs inside the carton are labelled Citalopram 40mg, please contact your pharmacy as soon as possible.” Patients who have taken Citalopram instead of Sertraline may experience side effects like nausea, headache, sleep disturbances, and mild anxiety.
Healthcare Professionals Mobilised
Pharmacists and clinicians have been instructed to identify and contact anyone who might have received the affected batch. Remaining tablets must be returned, and patient treatment plans reviewed. Special monitoring is recommended for those under 18, over 65, or with heart or liver conditions.
Report Side Effects
Any adverse reactions linked to the packaging error should be reported through the MHRA Yellow Card scheme. The MHRA stressed that supply of the impacted batch must cease immediately and stock returned to suppliers without exception.
