Staff Reporter
SPANISH health chiefs have withdrawn a popular antibiotic from shelves due to a defect in the sealing of some bottles.
The order was made in a directive from the Spanish Agency for Medicines and Health Products (AEMPS), which is linked to the Ministry of Health.
The affected medicine is Augmentine, produced by GlaxoSmithKline.
Specifically it is the 40ml bottle that is affected, with many not having been sealed properly.
The affected batch is ‘CP3W’, with the expiration date of August 31, 2025.
The AEMPS classifies quality issues in three categories (1, 2, and 3), with 1 representing the highest risk i.e. a risk to life.
In this case, the AEMPS points out that it is a class 2 defect, so it ‘does not pose a life-threatening risk to the patient.’
Distribution and dispensing networks have already been informed of this alert and a request has been made to withdraw all affected units from the market.
They will be returned to the laboratory, as is protocol.
‘Augmentine’ is used in adults and children to treat ear and sinus infections; respiratory tract infections; urinary tract infections and skin and soft tissue infections including dental, bone and joint infections. It is one of the most widely used antibiotics in the country.
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