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Action required over ‘precautionary’ recall of UK tamoxifen batch

A batch of tamoxifen 20mg film-coated tablets has been recalled as a precautionary measure following the identification of a ‘dissolution failure’ during stability testing, its manufacturer has announced.

Wockhardt UK Limited has recalled batch number HZ10030 (expiry date: 30/04/2027), distributed in packs of 30 tablets.

The batch of tamoxifen, which is used primarily to treat breast cancer, was first distributed on 22 August 2024.

In a recall alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA) on Monday, pharmacists were advised to immediately cease supplying the affected batch, quarantine remaining stocks, and return them via approved supplier processes.

The MHRA explained that patients should continue to take medicines as prescribed by their healthcare professional.

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‘The recall is being actioned at the pharmacy and wholesaler level as a precautionary measure,’ the alert said.

‘No complaints of harm or lack of efficacy have been received from patients regarding this batch.’

Patients who experience adverse reactions or have any questions about the medication are advised to seek medical attention, the MHRA added.

Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

A version of this article was originally published by our sister publication The Pharmacist.






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