Class 4 Medicines Defect Information: Sandoz Ltd., Risperidone 1mg, 2mg, 3mg Tablets, El(24)a/43
Recall Summary Sandoz Ltd. is recalling Risperidone 1mg, 2mg, and 3mg tablets distributed in the United Kingdom because important safety information is missing from the patient information leaflet and product characteristics document. The affected tablets are those supplied by Sandoz Ltd. in these three strengths.
- Product
- Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Risperidone 1mg, 2mg and 3mg and Tablets.
- Reason
- Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Risperidone 1mg, 2mg and 3mg and Tablets.
- Classification
- Class III
- Category
- drug recall
- Country
- United Kingdom
- Agency
- UK Medicines and Healthcare products Regulatory Agency
- Recall date
- 2024-09-26
- 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/35fa023f-145a-4c39-84af-aaff02d49d74