Carmustine 100 mg Powder and Solvent for Concentrate for Solution for Infusion (1 vial 100mg powder, 1 vial of 3 mL solvent)
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 2 recall · DMRC-38091819
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| 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 | carmustine | 05055565780602 |
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: