Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Baxter initiated recall of one lot of Doxil (doxorubicin hydrochloride liposome injection) in U.S due to exposure of product to temperature exceeding labelled storage conditions during transport. Labelled storage conditions for DOXIL is at 2°C- 8°C. Doxil liposomal infusion is indicated for ovarian cancer, sarcoma, Multiple Myeloma.
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