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 info@medacpharma.co.uk 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

DMRC@mhra.gov.uk

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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

Updates to this page

Published 4 July 2023