MHRA Recall: Sertraline 100mg film-coated tablets (Amarox Limited)

Amarox Limited is recalling one batch of Sertraline 100 mg film-coated tablets as a precautionary measure due to an error at the manufacturing site.

Affected Lot Batch Numbers:

Background

Amarox Limited is recalling one batch of Sertraline 100 mg film-coated tablets as a precautionary measure due to an error at the manufacturing site. Amarox Limited has received one complaint to date from an adult patient who reported the adverse event of headache, where it was identified that a pack of Sertraline 100 mg film-coated tablets (Batch Number V2500425) contains one blister strip of Citalopram 40 mg film-coated tablets inside the sealed carton.

Both products were manufactured at the same manufacturing site and the error appears to have occurred during secondary packaging of the blister strips into the cartons.

Stop supplying the affected batch of Sertraline 100 mg film-coated tablets (Batch Number V2500425) immediately. Quarantine all remaining stock and return it to your supplier using your approved returns process.

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

View the alert here