A defect notification has been issued for medicine used to treat a chronic condition that causes bones to become fragile.
Osteoporosis is a chronic condition that causes bones to become fragile, brittle and porous. It is often called the "silent disease" since its symptoms often goes unnoticed until what should be a minor injury results in broken bones.
The medicine is often used to treat women who have been through the menopause and men who have an increased risk of bone fracture, such as those receiving treatment for prostate cancer.
The warning was issued after Teva UK Limited reported that the cartons of three batches state "For application to the skin". The product is actually licensed for subcutaneous (or "under the skin") use.
Affected lot batch numbers are:
The product administration should be performed by a person who has been adequately trained in injection techniques. These batches, therefore, will not be repackaged.
Teva UK Limited have said that all future deliveries will be supplied with a copy of this notification. This will remind healthcare professionals and patients that the product is for subcutaneous use.
The notification states that there is no risk to product quality because of this labelling error.
Apart from the label, no other errors have been identified with the product or delivery device. The affected batches are therefore not being recalled.
Healthcare professionals are advised to reassure patients that the product is for injection as described in the information leaflet.
The leaflet contains clear instructions for use.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention.
Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.
