A Class 4 notice for several batches of Rosuvastatin 5mg, 10mg, 20mg and 40mg film-coated tablets (28s) in the Accord Healthcare livery has been issued. Affected batches are not being recalled.
The company has notified the MHRA that an older version of the patient information leaflet (PIL) lacking the most up to date safety information has been packaged in several batches. The missing information relates to:
- Section 2 – concomitant medication;
- Section 4 – possible side effects.
Healthcare professionals are advised to exercise caution when dispensing the product and where possible, provide an updated PIL.
The list of affected batch numbers and links to the latest versions of the PILs are given in the MHRA alert.