HomeHealthRegulators order recall of antidepressants due to labelling error

Regulators order recall of antidepressants due to labelling error

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A drug manufacturer is withdrawing one batch of an antidepressant following the discovery of labelling errors in certain packets.

Amarox Limited is carrying out the recall after receiving notification from a patient who was dispensed a carton of Sertraline 100mg tablets that contained a single blister strip of Citalopram 40mg instead.

Both treatments fall into the SSRI category and are used to manage depression and anxiety conditions, though ingesting the wrong formulation could provoke unexpected side effects.

Dr Alison Cave, the senior safety executive at the Medicines and Healthcare products Regulatory Agency, advised: patients whose prescription specifies Sertraline 100mg tablets and who received batch number V2500425 should confirm the contents match their requirements.

The batch code and use-by date are printed on the side of the external packaging.

Should the blister strips inside the box display Citalopram 40mg labelling, individuals should contact their dispensing chemist without delay.

If the blister packs are marked Sertraline 100mg, no further action is needed.

Anyone who has inadvertently consumed citalopram instead of—or together with—sertraline may experience heightened serotonergic activity.

These effects can include vomiting, migraines, disruptions to sleep cycles, and mild anxiety.

Both treatments are produced by the same company at the same manufacturing site, with the mix-up apparently occurring during the final packaging stage when blister strips were being placed into boxes.

The regulatory body is asking chemists and other healthcare practitioners to trace patients who may have obtained medications from the implicated batch and make contact with them.

Those identified should be advised to hand back any unused tablets and discuss with their GP or treating clinician whether a fresh prescription is warranted.

Doctors should also think about keeping certain patients under observation, including those aged below 18, over 65, or individuals with existing cardiac or hepatic conditions.

Any harmful incidents must be logged through the MHRA Yellow Card reporting mechanism.

Healthcare providers have been instructed to halt supply of the affected batch and return all remaining stock to their wholesalers.

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