Medicine recalls
|
| |
| The United Kingdom: National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Quetiapine Oral Suspension (unlicensed medicine), manufactured by Eaststone Limited due to a potential for overdosing |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that Eaststone Limited have informed MHRA that the formula they have used to manufacture all batches of quetiapine oral suspension products is incorrect. The active content is twice the amount that it should be which could lead to overdosing. The affected products are:
- Quetiapine 12.5 mg/5 ml Oral Suspension
- Quetiapine 25 mg/5 ml Oral Suspension
- Quetiapine 50 mg/5 ml Oral Suspension
- Quetiapine 100 mg/5 ml Oral Suspension
- Quetiapine 200 mg/5 ml Oral Suspension
For details of the affected batch numbers, please refer to the MHRA website.
Eaststone Limited have clarified that a total of 166 units/bottles were manufactured between 26 October 2025 and 26 January 2026 and distributed to healthcare customers. The remainder of bottles have been quarantined and will not be supplied. This notification includes batches that have expired. Any patients who have taken batches, including both expired and non-expired should be reviewed.
Patients should be advised not to stop any treatments without consulting their relevant healthcare professional and a treatment review should be initiated as soon as possible. Withdrawal of antipsychotic drugs after long-term therapy should always be gradual and closely monitored to avoid the risk of acute withdrawal syndromes or rapid relapse. Patients should be monitored for 2 years after withdrawal of antipsychotic medication for signs and symptoms of relapse.
Quetiapine is used in the treatment of schizophrenia and of bipolar disorder. It is also used for the symptomatic relief of unipolar depression in patients who are refractory to, or intolerant of, antidepressants.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-quetiapine-oral-suspension-unlicensed-medicine-manufactured-by-eaststone-limited-due-to-a-potential-for-overdosing-natpsa-slash-2026-slash-002-slash-mhr#download-documents
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Jan 30, 2026
Issued at HKT 17:30
|
| |
