Allergy Laboratories, Inc. - June 19, 2009

There is no documentation of approval from CBER for the reprocessing of un-standardized Eastern Cottonwood Allergenic Extract Lot #019031708, the technician noticed that the Laminar Flow Hood had been inadvertently turned off. QA instructed manufacturing to recap all previously filled final container vials and pour the contents in the bulk container. The extract that was malls in volume was again subjected to repeat sterilization, defiled into final containers, passed release tests and was released for distribution.