Class 4

Class 4 Medicines Defect Information: Strides Pharma UK Ltd, Liothyronine Sodium 5 & 20 micrograms Tablets, EL(24)A/58

Strides Pharma UK Ltd has informed MHRA of an error in the patient information leaflet (PIL) for Liothyronine Sodium 20 micrograms Tablets and Liothyronine Sodium 5 micrograms Tablets.

DMRC/MDR Number: DMRC-33999078

Company name: Strides Pharma UK Ltd

Product descriptions: 

Liothyronine Sodium 20 micrograms Tablets, PL 13606/0276 SNOMED Code 42474711000001108

Batch NoExpiry DatePack SizeFirst Distributed
EH23LIF00405/202528 Tablets25/09/2024
EH24LIF00108/202628 TabletsNot yet distributed

 

Liothyronine Sodium 5 micrograms Tablets, PL 13606/0275 SNOMED Code 42475111000001106

Batch NoExpiry DatePack SizeFirst Distributed
EH24LIE00108/202628 TabletsNot yet distributed

Brief description of problem:

Strides Pharma UK Ltd has informed MHRA of an error in the patient information leaflet (PIL) for Liothyronine Sodium 20 micrograms Tablets and Liothyronine Sodium 5 micrograms Tablets. The PIL incorrectly states the product name under section 5, the PIL should state ‘How to store Liothyronine Tablets’ but is written as ‘How to store Levothyroxine Tablets’.

Advice to Healthcare Professionals:

There is no impact on the product quality and the healthcare professionals should continue prescribing the medicine. This is a typographical error in one section of the PIL only, all other labelled information is correct.

Advice to Patients:

Patients should continue to take medicines from these batches as prescribed by your healthcare professional. This is a typographical error in one section of the PIL only, all other labelled information is correct.

If you experience any unexpected side effects or adverse reactions, these should be reported via the MHRA Yellow Card Scheme at https://yellowcard.mhra.gov.uk.

Company contacts for further information:

For medical information enquiries please contact Strides Pharma UK Ltd via email dl-drugsafety@strides.com or telephone +919844460742

For stock control enquiries please contact Strides Pharma UK Ltd via email customerservicesuk@stridespharma.co.uk or telephone 01923 255580

To access the full recall: Class 4 Medicines Defect Information: Strides Pharma UK Ltd, Liothyronine Sodium 5 & 20 micrograms Tablets, EL(24)A/58