Class 3 Medicines Recall: Azacitidine 100 mg/vial and 150 mg/vial Powder for Suspension for Injection, EL(25)A/08
Accord Healthcare Limited is recalling certain batches of Azacitidine Powder for Suspension for Injection 100 mg/vial and 150 mg/vial as precautionary measure due to out of specification results for Azacitidine related compound C impurity during stability testing.
DMRC Number: DMRC-34527566
Company name: Accord Healthcare Ltd.
Product descriptions:
Azacitidine 100 mg/vial Powder for Suspension for Injection - Licence: PLGB 20075/1408, SNOMED code: 38237411000001103, GTIN: 05055565759622
| Batch No. | 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 |
Azacitidine 150 mg/vial Powder for Suspension for Injection - Licence: PLGB 20075/1408, SNOMED code: 41314711000001108, GTIN: 05055565784150
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| P2302576 | 31/03/2026 | 1 vial pack | 05/07/2024 |
Brief description of problem:
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 to 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.
Advice to 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.
Company contacts for 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
To access the full recall: Class 3 Medicines Recall: Azacitidine 100 mg/vial and 150 mg/vial Powder for Suspension for Injection, EL(25)A/08