Medicines defect noticeMHRA
Onkotrone Injection 2 mg/ml concentrate for solution for infusion defect notice over a labelling error
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.
Check your product
Only products that match these details are covered. Have your pack in front of you.
28 identifiers listed for this notice.
Product 1 1 x 10 mL vial
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- 3L048A
- 3L048I
- 4E049Q
- 4J050J
- 4J050Q
- 4J050V
- 5B051B
- ExpiryOn the carton, blister or label.
- 30-Nov-2026
- 30-Apr-2027
- 30-Sep-2027
- 31-Jan-2028
- First distributedOn the product, its label or its packaging.
- 16-Oct-2024
- 30-Dec-2024
- 20-Feb-2025
- 14-Apr-2025
- 10-Jun-2025
- 7-Aug-2025
- 2-Oct-2025
Product 2 1 x 12.5 mL vial
- Batch code
- 3C045AA
- 3C045Y
- 3C045Z
- 5B051A
- Expiry
- 28-Feb-2026
- 31-Jan-2028
- First distributed
- 10-Feb-2025
- 29-Jul-2024
- 21-Oct-2024
- 12-Jun-2025
What to do now
The issue with Onkotrone Injection 2 mg/ml concentrate for solution for infusion is information: something on the packaging or leaflet is wrong or missing.
- Keep taking your medicine unless a healthcare professional tells you otherwise.
- Check the batch number and expiry date on your pack against the list on this page.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA Yellow Card scheme.
Why it matters. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
Symptoms and when to get help
Look out for
- a side effect you have not had before
- your condition not being controlled as well as usual
Get help urgently
- signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
- if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111
This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.
Replacements and prescriptions
Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.
If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/14). Quoted as issued.
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.
The risk
DMRC reference number DMRC-38016571 Marketing Authorisation Holder
Advice for healthcare professionals
Inform female patients of the necessity to use contraception and not become pregnant for at least 9 months after stopping this medication.
The updated PIL can be accessed on the Electronic Medicines Compendium (eMC):
Onkotrone Injection 2 mg/ml concentrate for solution for infusion - Patient Information Leaflet (PIL) - (emc) 1844
Upon request, Baxter Healthcare Corporation will provide hard copies of the updated PIL to wholesalers/pharmacies so that any remaining stock can be supplemented with the correct PIL information. To request hard copies of the PIL, please contact shs_regulatory_uk@baxter.com with your details, i.e. address, product with batch details, required number of leaflets.
It is important for female patients to use contraception for a period of at least 9 months after stopping taking this medication. It is important that you do not become pregnant during this period. If you have any questions about this issue, please contact your healthcare professional in the first instance.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Advice for patients
It is important for female patients to use contraception for a period of at least 9 months after stopping taking this medication. It is important that you do not become pregnant during this period. If you have any questions about this issue, please contact your healthcare professional in the first instance.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Open the MHRA notice
Questions
Why has Onkotrone Injection 2 mg/ml concentrate for solution for infusion been recalled?
The issue with Onkotrone Injection 2 mg/ml concentrate for solution for infusion is information: something on the packaging or leaflet is wrong or missing. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
How do I know if my medicine is affected?
Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.
What should I do now?
Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.
Do I need a new prescription?
Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.