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Wednesday, May 29, 2024

Drug series withdrawn from the market. “Increased risk to the patient”

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The Main Pharmaceutical Inspector informed about the recall of several batches of Detimedac from the market throughout the country. The reason is the finding of a quality defect, which may pose an increased risk to the patient.

GIF informed about the recall of several batches of Detimedac:

– Detimedac 100 mg (Dacarbazinum) powder for solution for injection or infusion 100 mg, lot number: D220154AA, expiry date: 04/30/2025, lot number: D220154AE, expiry date: 04/30/2025,

– Detimedac 200 mg (Dacarbazinum) powder for solution for injection or infusion 200 mg, lot number: F220255BA, expiry date: 31/05/2025,

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– Detimedac 500 mg (Dacarbazinum) powder for solution for injection or infusion 500 mg, batch number: G220299AD, expiration date: 30/06/2025.

The responsible entity is medac Gesellschaft für Klinische Spezialpräparate mbH with its registered office in Germany.

Quality defect

The above-mentioned MAH informed about the occurrence of a defect in the medicine, which informed GIF that there was a change in the color of the product to pink.

“The pink color may be due to the degradation of the active substance, which may pose an increased risk to the patient” – GIF reports in a release. Due to this defect, a decision was made to withdraw the above-mentioned batches of the drug.

Detimedac is an anti-cancer medicine that is used to treat patients with metastatic malignant melanoma. Other indications for the use of the drug are: advanced Hodgkin’s disease, advanced soft tissue sarcomas in adults (except mesothelioma and Kaposi’s sarcoma).

Main photo source: Shutterstock



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