Patient Safety AlertClass 1 · Immediate action
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/2026/002/MHRA
Read and act on the official notice on GOV.UK
Class 1 recall — Immediate action.
The MHRA uses Class 1 when:
The defect presents a risk of death or disability.
What all four recall classes mean
| Class | Action | The MHRA's definition |
|---|---|---|
| Class 1 this recall | Immediate action | The defect presents a risk of death or disability. |
| Class 2 | Action within 48 hours | The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious. |
| Class 3 | Action within 5 days | The defect is unlikely to cause harm to the patient. |
| Class 4 | Caution in use | Usually minor defects in packaging or other printed materials. |
A Class 1 recall usually comes with a National Patient Safety Alert. Source: MHRA, safety communications.
The MHRA's summary
Eaststone Limited is initiating a recall of all batches of quetiapine oral suspension products due to a potential risk of overdose, which could have consequences for the safety of patients.
MHRA's audience tags: All specialties