Class 4 Medicines Defect Information: Sandoz Ltd., Linezolid 600 Mg Film-coated Tablets, El(24)a/48

Sandoz Ltd.'s Linezolid 600 mg film-coated tablets are being recalled in the United Kingdom because the patient information leaflet and product safety information are missing required safety details. This recall affects all patients in the UK who have or may receive this medication. The manufacturer has notified health authorities about the incomplete safety documentation.

Recalling firm
Sandoz Ltd.
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 Linezolid 600 mg film-coated tablets.
Classification
Class III
Category
drug recall
Country
United Kingdom
Agency
UK Medicines and Healthcare products Regulatory Agency
Recall date
2024-10-10
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/ae208aaa-ae5b-41f5-9aff-bdd28568e240