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Direct Healthcare Professional Communication (DHPC) on Detimedac 500 mg and Detimedac 100 mg powder for solution for infusion of the company Medac: Recall of three batches

Active substance: Dacarbazine

Medac Gesellschaft für klinische Spezialpräparate mbH informs about a precautionary recall of the batches G220299AH, D220154AB and D220154AF of the medicinal product Detimedac 500 mg and Detimedac 100 mg powder for solution for infusion due to a pink discolouration of the solution immediately after reconstitution. 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.

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