Class 4 Defect: Baxter Onkotrone PIL Missing Contraception Duration Update
Summary
MHRA has issued a Class 4 Medicines Defect Notification for Baxter Healthcare Corporation's Onkotrone Injection 2mg/ml concentrate for solution for infusion in 10ml and 12.5ml vials. The Patient Information Leaflet (PIL) packed in eleven specified batches does not contain the updated contraception duration requirement, which was extended from four to nine months after cessation of therapy. Affected batches include 3L048A, 3L048I, 4E049Q, 4J050J, 4J050Q, 4J050V, 5B051B, 3C045AA, 3C045Y, 3C045Z, and 5B051A, distributed between July 2024 and October 2025. Healthcare professionals are advised to inform female patients to use contraception for at least nine months after stopping the medication, and updated PILs are available via the Electronic Medicines Compendium or upon request from Baxter.
“Inform female patients of the necessity to use contraception and not become pregnant for at least 9 months after stopping this medication.”
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
The defect notification identifies that eleven specific batches of Onkotrone Injection 2mg/ml distributed between October 2024 and October 2025 contain outdated Patient Information Leaflets. The PIL revision extends the required contraception duration for females from four months to nine months following cessation of therapy. Future batches will include the corrected PIL.\n\nHealthcare professionals in dispensing GP practices, haematology and oncology specialties, and pharmacy settings should identify any remaining stock from the affected batches and provide the updated contraception guidance to female patients. Wholesalers and pharmacies may request hard copies of the corrected PIL directly from Baxter Healthcare Corporation to supplement existing stock. Adverse reactions should be reported via the MHRA Yellow Card scheme.
What to do next
- 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)
- 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
Archived snapshot
Mar 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Class 4 Medicines Defect Notification: Baxter Healthcare Corporation, Onkotrone Injection 2 mg/ml concentrate for solution for infusion, EL(26)A/14
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.
From: Medicines and Healthcare products Regulatory Agency Published 17 March 2026 Message type: Medicines recall/notification Medical specialty: Dispensing GP practices, Haematology and oncology and Pharmacy Issued: 17 March 2026
DMRC reference number
DMRC-38016571
Marketing Authorisation Holder
Baxter Healthcare Corporation
Medicine Details
Onkotrone Injection 2mg/ml concentrate for solution for infusion in 10 ml vials
PL: 00116/0398
Active Ingredient: mitoxantrone hydrochloride
SNOMED code: 4466011000001103
Carton GTIN Number: 55413760208829,
Unit (vial) GTIN Number: 05413760208824
Onkotrone Injection 2mg/ml concentrate for solution for infusion in 12.5 ml vials
PL: 00116/0398
Active Ingredient: mitoxantrone hydrochloride
SNOMED code: 4467411000001109
Carton GTIN Number: 55413760208843
Unit (vial) GTIN Number: 05413760208848
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 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 |
Background
Baxter Healthcare Corporation have informed the MHRA that the Patient Information Leaflet (PIL) packed in the above batches does not contain up to date information relating to the duration of contraception required for females after stopping taking this medication.
The PIL for Onkotrone Injection 2mg/ml concentrate for solution for infusion, was updated regarding the duration of contraception for females and extended from four to nine months as follows: use effective contraception during therapy and for at least 9 months after cessation of therapy (PIL section 2). The specific batches listed in the table above do not contain this updated information in the PIL.
Future batches will contain the correct PIL.
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):
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 shsregulatoryuk@baxter.com with your details, i.e. address, product with batch details, required number of leaflets.
Advice for Healthcare Professionals to Provide to 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.
Additional information:
For all medical information enquiries regarding this communication, contact Baxter at MedInfo_UKI@baxter.com or telephone 0800 0260516
For stock control enquiries please contact Baxter at servicecs@baxter.com or telephone 0800 028 9881
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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