Amarox, the U.K.-unit of India’s Hetero Group, issued a voluntary recall of one batch of sertraline tablets in the United Kingdom after a patient found two different antidepressants packaged together.
The recall, covering 100-mg sertraline tablets, stems from a complaint that flagged a blister strip of a separate drug, 40-mg film-coated citalopram tablets, incorrectly included in the same sealed carton.
Now, the company is withdrawing the lot, given the potential for other blister packs of citalopram to turn up erroneously in its sertraline cartons.
Both sertraline and citalopram are selective serotonin reuptake inhibitors (SSRIs) that are prescribed to help treat depression, anxiety disorders and other related mental health conditions.
The recall notice was posted April 28 by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA). The batch under recall is coded V2500425.
The two antidepressants were produced at the same site and the packaging issue appears to have occurred during secondary packaging of the blister strips into the cartons, the regulator said in its notice.
The issue apparently came to light after Amarox received a complaint from a patient who reported the adverse event of a headache, leading to the identification of the mistakenly packaged citalopram.
“Patients who have accidentally taken citalopram instead of—or as well as—sertraline, may experience some heightened serotonergic side effects (that) can include nausea, headache, sleep changes and mild anxiety,” Alison Cave, MHRA chief safety officer, said in the notice.
Any patient prescribed sertraline who may have taken citalopram by mistake, or who is experiencing side effects, should seek medical advice immediately, the agency added.