GovWire

MDR number

MDR 226-02/23

Company name

Teva UK Limited

Product name

Levothyroxine 12.5mcg Tablets, PL 00289/1971

SNOMED Code

33617611000001109

Active Pharmaceutical Ingredients: Levothyroxine Sodium

Brief description of the problem

Teva UK Limited is recalling the above batch of Levothyroxine 12.5mcg Tablets in response to a lower than required assay result discovered during routine stability testing.

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your suppliers approved process.

Advice for patients

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Patients should continue to take medicines from this batch as prescribed by your healthcare professional.

If you are taking this batch of product and you experience any adverse reactions or insufficient control of symptoms, please seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Further Information

For any Levothyroxine stock enquiries please contact the Teva UK Limited Customer Solutions team on 0800 590 502.

For more information or medical enquiries, please contact Teva UK Limited by phone on 020 7540 7117 or by email to medinfo@tevauk.com

To report an adverse drug event to Teva UK Limited, please call 020 7540 7337, email uk.safety@tevauk.com or complete the online form at www.tevauk.com/Reporting-side-effects.

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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Class 2 Medicines Recall: Teva UK Limited, Levothyroxine 12.5mcg Tablets, EL (23)A/06