The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a class 4 defect notification for the osteoporosis medicine, ponlimsi (denosumab) 60mg solution for injection in a pre-filled syringe, due to a labelling error on the carton.
The warning was issued after Teva UK Limited reported that the cartons of three batches state ‘For application to the skin’ when the product is licensed for subcutaneous use.
Affected lot batch numbers:
- 184472 – expiring: 30/11/2028 – 1 pre-filled syringe – distributed: 21/01/2026
- 186711 – expiring: 30/11/2028 – 1 pre-filled syringe – distributed: 21/04/2026
- 188656 – expiring: 28/02/2029 – 1 pre-filled syringe – distributed: 01/06/2026
Because the product administration should be performed by an individual who has been adequately trained in injection techniques, these batches will not be repackaged and continue to be distributed.
Teva UK Limited have confirmed that all future deliveries will be supplied with a copy of this notification to help remind healthcare professionals and patients that this product is for subcutaneous use.
The notification states that there is no risk to product quality as a result of this labelling error. Aside from the labelling error, no additional errors have been identified with the product or delivery device; therefore, the affected batches are not being recalled.
Healthcare professionals are advised to reassure patients, if contacted, that the product is for subcutaneous injection as described in the patient information leaflet, which contain clear instructions for intended use.
Ponlimsi, which contains the active substance denosumab, is a medicine used to treat osteoporosis in women who have been through the menopause and in men who have an increased risk of fracture, such as those receiving treatment for prostate cancer.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
The error is circled in red on the image below:
MHRA
Have your say
Please add your comment in the box below. You can include links, but HTML is not permitted. Please note that comments are not moderated before publication and the views expressed are those of the user and do not reflect the views of The Pharmacist. Remember that submission of comments is governed by our Terms and Conditions. You can also read our full guidelines on article comments here – but please be aware that you are legally liable for any libellous or offensive comments that you make. If you have a complaint about a comment or are concerned that a comment breaches our terms and conditions, please use the ‘Report this comment’ function to alert our web team.