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.