Amarox Limited is recalling one batch of Sertraline 100mg
film-coated tablets as a precautionary measure due to a
manufacturing error that led to two antidepressant medicines
being packaged incorrectly.
The recall follows a patient complaint which
helped identify that a pack of Sertraline 100mg
film-coated tablets contained one blister
strip of Citalopram 40mg film-coated
tablets inside 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 SSRI medications 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 mistake or are experiencing side effects,
are advised to seek medical
advice immediately.
Dr Alison Cave, MHRA Chief Safety Officer,
said:
“If you have been prescribed Sertraline 100mg tablets and have
received batch number V2500425, please check
the carton contains the right medication. You can
find the batch number and expiry date printed on the side of the
outer packaging.
“If the blister strips inside
the carton are 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
include nausea, headache, sleep changes, and mild
anxiety.”
Pharmacists, or any other healthcare professionals involved
in dispensing should identify and contact any
patients who may have been dispensed the
impacted product 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 clinician responsible for the
care of the patient, to discuss treatment review and whether a
new prescription is required for ongoing
resupply.
Patients may need to be monitored by their doctor or another
healthcare professional, particularly if they are over 65 or
under 18, have cardiac or liver conditions, 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
supplying the affected batch and return all remaining
stock to their suppliers.
Notes to editors
