Merck has announced a voluntary recall of one lot of its MMR II vaccine after shipping doses to the US prior to final internal approval for market release.

The measles, mumps and rubella vaccines were shipped to customers between 17 and 25 May 2012.

Merck has insisted that there are no safety, quality or efficacy concerns with the product and revaccination is not necessary.

The company, however, stated that any adverse events that may occur when the vaccine is administered should be reported to FDA’s MedWatch Adverse Event Reporting programme online.

Adverse reactions, rarely serious, may occur from each component of an MMR vaccine. Around 10% of children develop fever, malaise and a rash five to 21 days after the first vaccination.

Customers who purchased the product from the affected lot (0851AA) will be contacted by Merck or its vaccine distributor with instructions for return.

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By GlobalData