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 name
Dacarbazine 100mg powder for solution for injection vials, PL 11587/0008
SNOMED Code
7323411000001109
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| D220154AD | 30/04/2025 | 10 | 26/02/2023 |
Product name
Dacarbazine 200mg powder for solution for injection vials, PL 11587/0008
SNOMED Code
10277911000001108
| 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 name
Dacarbazine 500mg powder for solution for injection vials, PL 11587/0010
SNOMED Code
7323511000001108
| 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 the 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 for 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 for 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.
Further Information
For all medical enquiries, please contact medical information at medac Pharma LLP by email to [email protected] or by telephone 01786 458086.
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
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