Teva UK Limited is reporting a labelling error on the carton for Ponlimsi (Denosumab) 60mg Solution for injection in Pre-filled Syringe. The carton states “For application to the skin” when the product is licensed for subcutaneous use.
DMRC Number: DMRC - 39320587
Company name:Teva UK Ltd
Product description: Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe - PL: 00289/2645, SNOMED code: 45668211000001103, GTIN: 5017007608233
Details of the affected batches:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| 184472 | 30/11/2028 | 1 pre-filled syringe | 21/01/2026 |
| 186711 | 30/11/2028 | 1 pre-filled syringe | 21/04/2026 |
| 188656 | 28/02/2029 | 1 pre-filled syringe | 01/06/2026 |
Background information:
Teva UK Limited is reporting a labelling error on the carton for Ponlimsi (Denosumab) 60mg Solution for injection in Pre-filled Syringe. The carton states “For application to the skin” when the product is licensed for subcutaneous use.
This notification contains batches that have commenced distribution from 21/01/2026 onwards. All 3 batches have been manufactured and packed with the erroneous carton, however as 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.
This error is circled in red on the image below:
Advice to Healthcare Professionals:
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.
The Summary of Product Characteristics and Patient Information Leaflet can be accessed at the following website https://products.tevauk.com/hcp/denosumab-823?productId=27077
Advice for Patients:
Patients should continue to use syringes from these batches as prescribed by your healthcare professional. This does not affect the quality of the medicine. The cartons contain a syringe for subcutaneous injection as prescribed, and this is a labelling error.
If you have concerns about a medicine you may be using, please contact your healthcare professional.
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.
Company contacts for further information:
For all medical information enquiries and information on this product, please email medinfo@tevauk.com
For stock control enquiries please email Customer.services@tevauk.com
To access the full recall/alert: Class 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe, EL(26)A/27