MHRA Class 3 Medicines Recall: Azacitidine 100 mg/vial and 150 mg/vial Powder for Suspension for Injection
MHRA Class 3 Medicines Recall: Azacitidine 100 mg/vial and 150 mg/vial Powder for Suspension for Injection
Drug Alert Number: EL(25)A/08
Date issued: 03 March 2025
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines recall notice for: Azacitidine 100 mg/vial and 150 mg/vial Powder for Suspension for Injection
DMRC reference number: DMRC-34527566
Product name: Azacitidine 100 mg/vial Powder for Suspension for Injection
SNOMED code: 38237411000001103
| Batch number | Expiry date | Pack size | First distributed |
| P2206998 | 30/11/2025 | 1 vial pack | 11/08/2023 |
| P2300471 | 30/11/2025 | 1 vial pack | 06/02/2024 |
Active ingredient: azacitidine
Product name: Azacitidine 150mg/vial Powder for Suspension for Injection
SNOMED code: 41314711000001108
| Batch number | Expiry date | Pack size | First distributed |
| P2302576 | 31/03/2026 | 1 vial pack | 05/07/2024 |
Active ingredient: azacitidine
Background
Accord Healthcare Limited is recalling the above batches of Azacitidine Powder for Suspension for Injection (100 mg/vial) & Azacitidine Powder for Suspension for Injection (150 mg/vial) as a precautionary measure due to out of specification results for Azacitidine related compound C impurity during stability testing. This recall is at pharmacy and wholesaler level.
Advice for healthcare professionals
Stop supplying the above batches immediately. Quarantine all stock from these batches and return it to your supplier using your supplier’s approved process. Accord Healthcare Limited is recalling the above batches as a precautionary measure, no adverse reactions have been reported with these batches to date.
View full alert here.
Advice for patients
Patients are not required to take any action. This product is administered by healthcare professionals only. Patients who experience adverse reactions or have any questions about the medication, should seek medical attention.
Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Further Information
For medical information enquiries please contact Accord-UK Ltd Medical Information Department on 01271 385257 or email medinfo@accord-healthcare.com
For stock control enquiries please contact Accord-UK Ltd Customer Services Team on 0800 373573
