October 11th 2024

By Ailsa Colquhoun

Alert: trandolapril, Linezolid 600mg

Generics (UK) Ltd T/A Mylan UK is recalling 11 batches of trandolapril 2mg and 4mg tablets after re-testing showed out of specification results. The listed batches are being recalled as a precautionary measure.

View the affected batches.

Healthcare professionals are asked to quarantine all remaining stock and return it to your supplier using your supplier’s approved process. No action is required by patients  

For medical information enquiries please contact Viatris UK Healthcare Limited Medical Information at +44 (0)1707 853 000 (select option 1) or info.uk@viatris.com.

For stock control enquiries please contact Customer Services at +44 (0)1707 853 000 (select option 2).

In addition, Sandoz Ltd. has alerted the MHRA to missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for one batch of Linezolid 600 mg film-coated tablets. The affected batch is: 

 The missing information from the SmPC is already covered under other sections:

• The missed extension of thrombocytopenia to patients with hepatic impairment under section 4.4 of the SmPC is already included in same section under sub section special population where it is recommended that linezolid should be given to patients with severe hepatic insufficiency only when the perceived benefit outweighs the theoretical risk. Hyponatremia and/ (SIADH) is already listed twice under section 4.8 of the SmPC under metabolism disorders & investigations
• The missed ADR of Hypersensitivity vasculitis missing under section 4.8 of the SmPC SOC skin & subcutaneous tissue disorders is covered under broader topic as a contraindication in section 4.3
• The missed warning under section 4.4 of the SmPC on Impairment of fertility is limited to adult male rats and already covered under section 4.6 of the SmPC “Fertility, pregnancy & lactation”.
• The missed frequency upgrade in section 4.8. are considered of minor impact for patient safety. All ADRs for which frequency has been updated are already listed in the SmPC.

Healthcare professionals are advised to review the content of this notification. Patients do not need to take any action.  

For medical information queries, please contact: sandozgb@EU.propharmagroup.com, Telephone: +44 1276 698 101.

For stock control queries, please contact: sales.sandoz-gb@sandoz.com , Telephone: +44 1276 698607.