LONDON, April 28 -- The government of the United Kingdom issued the following news:
Amarox Limited is recalling one batch of Sertraline 100mg film-coated tablets as a precautionary measuredue to a manufacturing errorthat led to two antidepressant medicines being packaged incorrectly.
The recallfollowsapatientcomplaint which helpedidentifythat a pack of Sertraline 100mg film-coatedtablets contained oneblister stripofCitalopram 40mg film-coated tabletsinside the sealed carton.
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.
Both SSRImedications are produced by the same manufacturer, at the same site, and the error appears to have occurred during secondary packaging of the blister strips into the cartons.
Patients who believe they have already taken any Citalopram 40mg tablets by mistakeorare experiencing side effects, areadvised to seekmedical adviceimmediately.
Dr Alison Cave, MHRA Chief Safety Officer, said:
"If you have been prescribed Sertraline 100mg tablets and have received batch number V2500425, please check thecartoncontains the right medication. Youcan find the batch number and expiry date printed on the side of the outer packaging.
"If theblisterstripsinside thecartonare labelled Citalopram 40mg, please contact your pharmacy as soon as possible. If they are labelled Sertraline 100mg, no further action is needed."
"Patients who have accidentally taken citalopram instead of -or as well as- sertraline,may experience some heightened serotonergic side effects. These can includenausea, headache, sleepchanges, and mild anxiety."
Pharmacists, or any other healthcare professionalsinvolved in dispensingshouldidentify andcontactany patients whomay havebeen dispensed the impactedproduct and request it be returned if they have any remaining medicine.
If any patients are identified with this product, pharmacists and other healthcare professionals involved in dispensing should contact the patients' GP, or clinicianresponsible for the care of the patient, to discuss treatment review and whether a new prescription isrequiredfor ongoing resupply.
Patients may need to be monitored by their doctor or another healthcare professional, particularly if they are over 65 or under 18, havecardiac or liverconditions,or have been told that their body processes certain medicines differently.
Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
The MHRA has advised healthcare professionals to stop supplyingthe affected batch and return allremaining stock to their suppliers.
Notes to editors
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Please seeMHRA's Class 2 recall forfurther informationand images of the affected product.
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The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
Disclaimer: Curated by HT Syndication.
