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MHRA recalls Tetrabenazine 25 mg tablets

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The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for Tetrabenazine 25 mg tablets.

AOP Orphan Pharmaceuticals is recalling all unexpired stock of the product with batch number T1704UK from pharmacies and wholesalers as a precautionary measure. This is due to out of specification results for the assay, obtained during routine stability testing.

Pharmacists are asked to stop supplying the product immediately, quarantine remaining stock and return it to the supplier using the approved process.

Batch Number Expiry Date Pack Size First Distributed
T1704UK 09/2020 112 31/12/2017

 

The Department of Health and Social Care (DHSC) also issued a medicine supply notification for Valproate semisodium (Depakote) 250mg and 500mg tablets.

Depakote 500mg tablets are out of stock until early April 2020 while the 250mg tablets will be out of stock from early March until early April 2020.

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