Class 2 Medicines Recall: Accord Healthcare Ltd, Carmustine 100 mg Powder and Solvent for Concentrate for Solution for Infusion (1 vial 100mg powder, 1 vial of 3 mL solvent), EL(26)A/05
Accord Healthcare limited is recalling a single batch due to an out of specification test result.
DMRC reference number
DMRC-38091819
Marketing Authorisation Holder
Accord Healthcare Ltd
Medicine Details
Carmustine 100 mg Powder and Solvent for Concentrate for Solution for Infusion (1 vial 100mg powder, 1 vial of 3 mL solvent)
PL: 20075/1385
Active ingredient: carmustine
SNOMED code: 44952111000001109
GTIN: 05055565780602
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| M2408383 | 31 Jul 2026 | 100mg/3mL per vial | 16/06/2025 |
Background
Accord Healthcare Limited (Accord-UK Ltd) is recalling a batch of Carmustine 100 mg Powder and Solvent for Concentrate for Solution for Infusion (1 vial 100mg powder, 1 vial of 3 mL solvent) due to an out of specification result for Non-Volatile Residue observed during Official Medicines Control Laboratory (OMCL) testing.
The batch is being recalled as a precautionary measure, no adverse reactions have been reported with this batch to date.
Advice for Healthcare Professionals:
Stop supplying the above batches immediately. Quarantine all stock from this batch and return it to your supplier using your supplier’s approved process.
Advice for Patients:
Patients are not required to take any action. This product is administered by healthcare professionals only and this recall is being undertaken at a Pharmacy and Wholesaler level. Patients who may have had this batch of product administered should note that the recall is being enacted out of an abundance of caution and no adverse event or lack of efficacy reports have been received.
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 on https://yellowcard.mhra.gov.uk/
Additional information:
For medical information enquires please contact Accord Medical Information Department on 01271 385257 or email medinfo@accord-healthcare.com.
For stock control enquiries please contact our Customer Services Team on 0800 373573.
Recipients of this Medicines Recall 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