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Flu drug recalled following ‘qualify defects’

Novartis asked to withdraw 160,000 doses of Agrippal

Mark Gould

Thursday, 01 November 2012

The UK drugs regulator has asked a manufacturer to recall two batches of flu vaccine after the company reported “quality defects”.

While the recall involves 160,000 doses the Medicines and Healthcare products Regulatory Agency (MHRA) which asked for the recall, said it was a “relatively small proportion” of all the doses available in the UK and would have minimal impact on flu vaccine supplies.

The move follows a halt on use of Agrippal vaccine by several EU countries including Italy, France and Germany.

A spokesman for the MHRA said that while there were no current safety concerns for anyone who had already received the vaccine they would continue to monitor the situation.

The spokesperson said: “We have asked Novartis to issue a precautionary recall of two batches of Agrippal vaccine.

“The decision was made after the company reported quality defects with the vaccine which do not currently indicate a safety issue for those who received the vaccine.

“Patients should not be unduly concerned. The recall is being taken as a precautionary measure. There is no evidence of a safety issue with this vaccine either in the UK or other European countries. ”

The MHRA says that it important that GPs and nurses should inspect vaccine

syringes or vials before administration to ensure the colour and composition conforms to the SPC description. “Vaccines which do not conform should be disposed of appropriately. If a product defect is suspected, this should be reported to the MHRA.”

In October GPs warned of vaccine shortages after pharmaceutical company Crucell withdrew its vaccines after problematic test results were found with two batches.

The Department of Health came under criticism from GPs for lacking any emergency supplies to help practices who were relying on vaccine supplied from Crucell.

A DH review of flu vaccine procurement carried out last year recommended a central stockpile was needed, but as in previous years, reserves will be built up at the end of the season, the DH said.

Novartis confirmed the recall is a precautionary measure following identification of visible protein aggregates in one batch of Agrippal manufactured in Italy, which was not released for distribution.

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