Amarox Limited\u202fis recalling\u202fone\u202fbatch\u202fof\u202fSertraline 100mg film-coated tablets as a precautionary measure\u00a0due to\u202fa manufacturing error\u00a0that led to two antidepressant medicines being packaged\u202fincorrectly.\u202f\u00a0<\/p>\n
The recall\u00a0follows\u00a0a\u00a0patient\u00a0complaint which helped\u00a0identify\u00a0that a pack of Sertraline 100mg film-coated\u00a0tablets\u202fcontained\u202fone\u00a0blister strip\u00a0of\u00a0Citalopram 40mg film-coated tablets\u00a0inside the sealed carton.\u202f\u202f\u00a0<\/p>\n
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.\u00a0\u00a0<\/p>\n
Both\u202fSSRI\u00a0medications are\u202fproduced\u202fby the same manufacturer, at\u202fthe same site,\u202fand the error appears to have occurred during secondary packaging of the blister strips into the cartons.\u202f\u202f\u00a0<\/p>\n
Patients who believe they have already taken any Citalopram 40mg tablets by mistake\u00a0or\u00a0are experiencing side effects, are\u00a0advised to seek\u00a0medical advice\u00a0immediately.\u00a0<\/p>\n
Dr Alison Cave,\u202fMHRA Chief Safety Officer, said:\u202f\u202f\u00a0<\/p>\n
\u201cIf you have been prescribed Sertraline 100mg tablets and have received batch number V2500425, please check the\u00a0carton\u00a0contains the right medication. You\u00a0can find the batch number and expiry date printed on the side of the outer packaging.\u00a0<\/p>\n
\u201cIf the\u00a0blister\u00a0strips\u00a0inside the\u00a0carton\u00a0are labelled Citalopram 40mg, please contact your pharmacy as soon as possible. If they are labelled Sertraline 100mg, no further action is needed.\u201d\u00a0<\/p>\n
\u201cPatients who have accidentally taken citalopram instead of –\u00a0or as well as\u00a0– sertraline,\u00a0may experience some heightened serotonergic side effects. These can include\u00a0nausea, headache, sleep\u00a0changes, and mild anxiety.\u201d\u00a0<\/p>\n
Pharmacists, or any other healthcare professionals\u00a0involved in dispensing\u00a0should\u00a0identify and\u00a0contact\u00a0any patients who\u00a0may have\u00a0been dispensed the impacted\u00a0product and request it be returned if they have any remaining medicine.\u00a0\u00a0<\/p>\n
If any patients are identified with this product, pharmacists and other healthcare professionals involved in dispensing should contact the patients\u2019 GP, or clinician\u00a0responsible for the care of the patient, to discuss treatment review and whether a new prescription is\u00a0required\u00a0for ongoing resupply.\u00a0<\/p>\n
Patients may need to be monitored by their doctor or another healthcare professional, particularly if they are over 65 or under 18, have\u00a0cardiac\u202for liver\u00a0conditions,\u00a0or have been told that their body processes certain medicines differently.\u00a0<\/p>\n
Any\u202fsuspected adverse reactions should also be reported via\u202fthe\u202fMHRA Yellow Card scheme<\/a>.\u202f\u202f\u00a0<\/p>\n The MHRA\u202fhas\u202fadvised healthcare professionals to\u202fstop supplying\u00a0the affected batch and return all\u00a0remaining stock to their suppliers.\u202f\u202f\u00a0<\/p>\n Notes to editors\u202f\u202f\u202f\u202f\u202f\u00a0<\/p>\n