Baxter International ($BAX) has issued a Class 1 (immediate action) recall for two batches of its Preflucel flu vaccine in the U.K. and directed healthcare providers that none of the vaccine--from any batches--should be used now. The callback covers 300,000 doses, reports Aberdeen's The Press and Journal. It is precautionary and was triggered by a greater number of adverse reaction reports than expected.
The recall involves batches of the low-egg-content prophylactic distributed in early September, primarily in Ireland and Scotland. It has been issued to healthcare providers and wholesalers.
"The vaccine should no longer be used and any remaining stock [of the recalled batches] should be returned to the original supplier for credit. No further Preflucel of any batch should be administered at this time," says a listing on the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) website.
A third batch has been quarantined "in the supply chain" pending investigations.
The adverse events have mostly been mild and short-lived, according to the listing, and are of "the types usually associated with influenza vaccines." The cause is unknown but is being investigated by Baxter and the MHRA.
Also unknown is when additional batches will be available. Alternative low-egg-content vaccines are available, however, so the regulator expects no supply shortage.