Ventolin Syrup sugar-free 2mg in 5ml - risk of glass fragments in the bottles
(Glaxo Wellcome UK Ltd) Source of possible contamination is believed to be sucrose used within this formulation of Questran – potential risk of glass fragments in bottles due to defect identified in very small number of bottles – class 2 action within 48 hours. (EL (13)A/16)
14 June 2013
Class 2 medicines recall
Action within 48 hours
Patient-level recall
MDR 06-06/13
Product details
Glaxo Wellcome UK Ltd trading as Allen & Hanburys
Ventolin Syrup sugar-free 2mg in 5ml
Salbutamol
PL 10949/0088
Alert details
- Batch number: M005
- Expiry date: 29 Feb 2016
- Pack size: 150ml
- First distributed: 26 Apr 2013
- Batch number: M006
- Expiry date: 29 Feb 2016
- Pack size: 150ml
- First distributed: 26 Apr 2013
Glaxo Wellcome UK Ltd is recalling the above batches because there is a potential risk of glass fragments in the bottles due to a defect which has been identified in a very small number of bottles. No complaints or adverse reactions relating to this issue have been received by the company to date.
Pharmacists and clinics are requested to contact patients to whom they have dispensed Ventolin Syrup sugar-free 2mg in 5ml since 26 April 2013 and ask them to return any remaining stock of these affected batches only. The company has informed us that alternative batches are available but due to this issue, the supply situation is currently fragile.
Please ensure that affected patients are not left without a supply. For stock information, please contact either AAH or Alliance Healthcare.
NB only the above batches are affected by this issue. Please ensure that only stock from these batches is returned by patients as the supply situation is currently very fragile.
All unused stock of the listed batches should be quarantined and returned to the original supplier for credit. For returns and credit enquiries, please contact either AAH or Alliance Healthcare.
For medical information enquiries, please contact GlaxoSmithKline UK Medical Information Department on 0800 221441, option 2.
Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.