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 reference number
DMRC-34527566
Marketing Authorisation Holder
Accord Healthcare Ltd.
Medicine Details
Azacitidine 100 mg/vial Powder for Suspension for Injection
Licence: PLGB 20075/1408
Active ingredient: azacitidine
SNOMED code: 38237411000001103
GTIN: 05055565759622
Affected Lot Batch Numbers
| 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 |
Medicine Details
Azacitidine 150 mg/vial Powder for Suspension for Injection
Licence: PLGB 20075/1408
Active ingredient: azacitidine
SNOMED code: 41314711000001108
GTIN: 05055565784150
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| P2302576 | 31/03/2026 | 1 vial pack | 05/07/2024 |
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.
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.
Additional 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
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
Download document