RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Baxter Healthcare Corporation, Onkotrone Injection 2 mg/ml concentrate for solution for infusion, EL(26)A/14
Read and act on the official notice on GOV.UK
Class 4 recall — Caution in use.
The MHRA uses Class 4 when:
Usually minor defects in packaging or other printed materials.
What all four recall classes mean
| Class | Action | The MHRA's definition |
|---|---|---|
| Class 1 | 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 this recall | 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
Baxter Healthcare Corporation have informed the MHRA that the Patient Information Leaflet (PIL) packed in specified batches does not contain up to date information relating to the duration of contraception required for females after stopping taking this medication.
Affected batches
As listed by the MHRA, exactly as published. Always check against the GOV.UK notice before acting.
| Batch number | Expiry | Pack size | First distributed |
|---|---|---|---|
| Onkotrone Injection 2mg/ml concentrate for solution for infusion in 12.5 ml vials | |||
| 3L048A | 30-Nov-2026 | 1 x 10 mL vial | 16-Oct-2024 |
| 3L048I | 30-Nov-2026 | 1 x 10 mL vial | 30-Dec-2024 |
| 4E049Q | 30-Apr-2027 | 1 x 10 mL vial | 20-Feb-2025 |
| 4J050J | 30-Sep-2027 | 1 x 10 mL vial | 14-Apr-2025 |
| 4J050Q | 30-Sep-2027 | 1 x 10 mL vial | 10-Jun-2025 |
| 4J050V | 30-Sep-2027 | 1 x 10 mL vial | 7-Aug-2025 |
| 5B051B | 31-Jan-2028 | 1 x 10 mL vial | 2-Oct-2025 |
| 3C045AA | 28-Feb-2026 | 1 x 12.5 mL vial | 10-Feb-2025 |
| 3C045Y | 28-Feb-2026 | 1 x 12.5 mL vial | 29-Jul-2024 |
| 3C045Z | 28-Feb-2026 | 1 x 12.5 mL vial | 21-Oct-2024 |
| 5B051A | 31-Jan-2028 | 1 x 12.5 mL vial | 12-Jun-2025 |
MHRA's audience tags: Dispensing GP practices, Haematology oncology, Pharmacy