Reference

Drug alert 03/2021

Name

Drug alert class 4 no. 03 2021 class 4 medicines defect information caution in use - Gilead Sciences Ltd – Ambisone Liposomal 50MG powder for dispersion for infusion

Categories

Scottish Government Drug Alerts

Organization

Scottish Government Health and Social Care Directorates

Keywords

NHS SCOTLAND DRUGS SAFETY RISKS PHARMACEUTICAL INDUSTRY DRUG THERAPY PHARMACEUTICAL SERVICES

Description

Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5μm sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-K. The device manufacturer has informed Gilead that the filter lots packaged with the AmBisome batches listed in this notification may be releasing fibres and particles, which may pose a risk to the patient. There is no quality issue associated with AmBisome product and due to supply considerations, the product is not being recalled. Gilead Sciences Ltd have confirmed that no further affected stock will be distributed, whilst they re-package packs with the correct filter. For packs already with wholesalers these will not be distributed onwards, until a replacement filter is provided by Gilead Sciences Ltd, to be provided with the impacted batches at the point of distribution. New filters will be available with packs w/c 15 February 2021.

Contact Name

Irene Fazakerley

Contact Email

Contact Address

Chief Medical Officer Directorate Pharmacy and Medicines Division St Andrew’s House Regent Road Edinburgh EH1 3DG

Contact Phone

Created

2021-02-11 00:00:00

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