Product Defect Correction
HPS Pharmacies wish to advise that Gilead, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a product defect correction for AmBisome® as follows:
Liposomal amphotericin 50mg
This product defect correction has been initiated in response to a quality defect identified with the 5μm sterile filters co-packed with the AmBisome® product. The affected filters are called Minisart® Filter 17594-GJ. Specific lots of these filters may be releasing particles and fibres, which could pose a risk to the patient.
The only AmBisome® lots affected by this issue are:
- 025620 (Exp 31 July 2024)
- 027928 (Exp 30 September 2024)
- 028018 (Exp 31 August 2024)
Please inspect your stock as soon as possible. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity.
If affected stock is identified, the defective Minisart® filters should be removed from the carton and disposed of appropriately. Other suitable 5μm sterile filters may be available in your facility, and filters from an alternative supplier are available from Gilead.
Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.
Should you require further information regarding this matter, please contact Gilead on (03) 9272 4432, or your pharmacist at HPS Pharmacies.
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