Class 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (denosumab) 60mg Solution For Injection In Pre-filled Syringe, El(26)a/27
Ponlimsi (Denosumab) Recall Summary Teva UK Ltd is recalling Ponlimsi 60mg pre-filled syringes because the carton labeling incorrectly states "For application to the skin" when the medicine is actually meant to be injected under the skin. The recall affects Ponlimsi distributed in the United Kingdom.
- Recalling firm
- Teva UK Ltd
- Reason
- 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.
- Classification
- Class III
- Category
- drug recall
- Country
- United Kingdom
- Agency
- UK Medicines and Healthcare products Regulatory Agency
- Recall date
- 2026-06-04
- Status
- Ongoing
- Distribution
- United Kingdom
Official recall notice from UK Medicines and Healthcare products Regulatory Agency
Recall details on Nibble Recalls: https://trynibble.app/recalls/653c351c-937c-478a-aee5-648f9b90818f