AmBisome 50mg Powder for Solution for Infusion - potential lack of sterility assurance

(Gilead Sciences International Limited) Remaining stocks of affected batches should be quarantined and returned to the original supplier for credit – class 1 action now. (EL (13)A/17)

18 June 2013

Class 1 medicines recall

Action now – including out of hours

Hospital, pharmacy and ward-level recall

MDR 25-06/13

Product details

Gilead Sciences International Limited

AmBisome 50mg Powder for Solution for Infusion

(Liposomal Amphotericin B)

PL 16807/0001

Alert details

Batch number   Expiry date   Pack size   First distributed
042263AD1   30 June 2015   10 x 50mg vials   30 November 2012
042264AD   30 June 2015   10 x 50mg vials   7 December 2012
042285AD   31 August 2016   10 x 50mg vials   4 January 2013
0422A6AD   31 October 2016   10 x 50mg vials   14 March 2013
042311AD   31 January 2017   10 x 50mg vials   15 May 2013

Gilead Sciences International Limited is recalling the above batches as a precautionary measure due to a potential lack of sterility assurance. No complaints or adverse reaction reports which may be related to this issue have been received by the company to date.

Remaining stocks of affected batches should be quarantined and returned to the original supplier for credit. For stock enquiries, please contact Gilead Customer Services by phone on 01223 897400 or by email at ukcustomer.services@gilead.com.

For medical information enquiries please contact Gilead Medical Information by phone on 01223 897312 or by email at ukmedinfo@gilead.com.

Recipients of this drug alert should bring it to the attention of relevant professionals by copy of this letter.

Download documents

Help us improve GOV.UK

Don’t include personal or financial information, eg your National Insurance number or credit card details.