Class 4 Medicines Defect Information: Sandoz Ltd., Rosuvastatin 20mg, 40mg Tablets, El(24)a/45

Sandoz Ltd. Rosuvastatin 20mg and 40mg tablets sold in the United Kingdom are missing required safety information from their patient leaflet and product information documents. The missing safety details were identified by the manufacturer and reported to the UK medicines regulator. This affects patients who have received these tablets.

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 Rosuvastatin 20mg and 40mg 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 Rosuvastatin 20mg and 40mg Tablets.
Classification
Class III
Category
drug recall
Country
United Kingdom
Agency
UK Medicines and Healthcare products Regulatory Agency
Recall date
2024-10-01
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/832368f7-d0c3-451e-88b6-1fe764b3bfc6