The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a Class 2 Drug Alert due to a risk of glass particles being contained within bottles of the asthma treating syrup marketed by Glaxo Wellcome UK Ltd, trading as Allen & Hanburys.
Speaking with in-Pharmatechnologist.com, Eleanor Bunch - a spokesperson from GSK - said the issue stemmed from the company’s “contract manufacturer of the bottle at a site in France manufacturer in France who notified GSK of this defect.”
She continued, adding: “We’ve carried out a thorough investigation with them, to identify the source of the defect, and the likely percentage of defects in the manufactured batches – and we’ve now put in place actions with the manufacturer and their supplier to prevent this from happening again.”
The issue does not affect any other products in glass bottle containers which are supplied by GSK.
Furthermore the recall is precautionary, according to the UK regulators, as such a risk is low:
“There have been 1375 bottles of the affected batches dispensed to pharmacies and there is less than a one in 1000 chance of a bottle having a defect which could potentially result in glass fragments being contained in these” the MHRA said in a statement.
The UK recall affects sugar-free 2mg in 5ml bottles of the drug displaying the batch numbers M005 or M006 which were distributed April 26 2013.
However, Bunch said a total of 15 Ventolin Syrup 2.5mg/5ml – 150ml packed batches have been affected in international markets. Belgium, Cyprus, Estonia, Holland, Lithuania, Malta and African Francophone countries have all been affected by the defect.