Class 4 Medicines Defect Information, AmBisome Liposomal 50 mg Powder for dispersion for infusion, (PL 16807/0001), EL (21)A/03
Gilead Sciences Ltd has informed of a quality defect issue, in relation to specific lots of 5µm sterile filters, co-packed in cartons of the AmBisome product. As there is no quality issue the product is not being recalled, but instructions for disposal of filters is provided.
Source:
Medicines and Healthcare products Regulatory Agency