LONDON, Jan. 29 -- The government of the United Kingdom issued the following news:
All batchesofquetiapine oralsuspensionmanufactured by Eaststone Limited are being recalled due to a manufacturing error that has resulted in the productcontainingtwice the amount of active ingredient (quetiapine fumarate) than it should, which could potentially result inanoverdose.
Quetiapine oral suspensionis supplied as an unlicensed'special'medicinefor the management of psychiatric conditions including schizophrenia, bipolar disorder, and as an add-on treatment for depression, where licensed options are not suitable for the patient.
The manufacturer hasadvisedthe Medicines and Healthcare products Regulatory Agency (MHRA) that it is has full traceability of healthcare customers they have supplied directly and has already initiated communications and recall action.
A totalof166bottlesof the affected productweremanufactured between26 October 2025 and 26 January 2026.
Patients taking this medicine should check to see if they have any of the batches at home and if theyhaven'tyet been contacted,they'readvised to speakto a healthcare professional responsible for their care. The batch number and expiry date can be found on the bottle and/or dispensing label. Those unsure or unable tolocatethe batch number and expiry date, should contact their pharmacist for further advice.
Dr Alison Cave, MHRA Chief Safety Officer, said:
"It is important that patients do not stop taking their medication until they have spoken to their doctor. Suddenly stopping antipsychotic medication carries risks of severe side effects, including acute withdrawal syndromes or rapid relapse.
"Patientsshouldbe aware of the symptoms of overdose, which include extreme drowsiness, vomiting, dizziness or confusion, and slow or shallow breathing. If you experience any of these symptoms, please seek immediate medicalassistanceor visit your nearest accident and emergency centre.
"Anyone who has questions about their medication shouldspeak to their healthcare professional. We also encourage patients to report any suspected adverse reactions via theMHRA Yellow Card scheme."
Pharmacy and other healthcare professionals involved in dispensing these products are advised toidentifyandimmediatelycontact all affected patients to confirm if they haveany remaining medicine. GPs and specialist clinicians will need to review these patients as soon as possible and consider ongoing treatment options, including switching to alternatives.Patients who have taken the affected batches previously may also be contacted for a review.
Further information is available in theNational Patient Safety Alert.
Notes to editors
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For further information about affected products, including batch numbersand how tolocatethese, pleaserefer to theNational Patient Safety Alert.
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'Specials' are products which have been specially manufactured or imported for the treatment of an individual patient. For more information, visit:Supply unlicensed medicinal products (specials) - GOV.UK
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The Medicines and Healthcare products Regulatory Agency (MHRA)is responsible forregulating all medicines and medical devices in the UK by ensuring they workand 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.