Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Dacarbazine 100mg, 200mg & 500mg powder for solution for injection vials, EL(23)A/22
medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to pink discolouration of the dacarbazine solution immediately after reconstitution (after correct preparation and storage).
MDR Number: MDR 228-06/23
Company name: medac GmbH (t/a medac Pharma LLP)
Product description: Dacarbazine 100mg powder for solution for injection vials, PL 11587/0008
SNOMED Code: 7323411000001109
Details of the affected batch:
|
Batch number |
Expiry date |
Pack size |
First distributed |
|
D220154AD |
30/04/2025 |
10 |
26/02/2023 |
Product description: Dacarbazine 200mg powder for solution for injection vials, PL 11587/0008
SNOMED Code: 10277911000001108
Details of the affected batch:
|
Batch number |
Expiry date |
Pack size |
First distributed |
|
F220255A |
31/05/2025 |
10 |
06/10/2022 |
|
F220288A |
30/06/2025 |
10 |
08/12/2022 |
Product description: Dacarbazine 500mg powder for solution for injection vials, PL 11587/0010
SNOMED Code: 7323511000001108
Details of the affected batch:
|
Batch number |
Expiry date |
Pack size |
First distributed |
|
G220299AE |
30/06/2025 |
1 |
09/11/2022 |
Active Pharmaceutical Ingredient: dacarbazine (as dacarbazine citrate)
Brief description of problem:
medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to pink discolouration of the dacarbazine solution immediately after reconstitution (after correct preparation and storage). As stated in the Summary of Product Characteristics (SmPC), the diluted solution for infusion should be visually inspected and only clear solutions practically free from particles should be used. Do not use the solution if particles are present. The pink discolouration is caused by a degradation product of dacarbazine and may cause a venous irritation in the patient when the product is applied.
Advice to Healthcare Professionals:
Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Advice to Patients:
No further action is required by patients as this is a Pharmacy and Wholesaler level recall. This product is administered by healthcare professionals directly. If you have concerns about a medicine you may be using, please contact your healthcare professional.
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 all medical enquiries, please contact medical information at medac Pharma LLP by email to info@medacpharma.co.uk or by telephone 01786 458086.
To access the full recall:
https://assets.publishing.service.gov.uk/media/64a4084a0ce7d40013fccfca/EL_23_A22_Final.pdf