Makhteshim Agan, Control Solutions File Notification In U.S. District Court
Makhteshim Agan of North America (MANA) and Control Solutions Inc. (CSI) today filed a notification in the United States District Court for the Middle District of North Carolina acknowledging that, due to a one-time human error, two lots of Taurus SC product were not formulated with fipronil technical material made in accordance with a process known as the “Currently Intended Process”.
CSI launched the fipronil-based Taurus SC product in June 2011 following EPA and court approval for sale in the US. MANA’s and CSI’s process for manufacturing fipronil uses Makhteshim Agan Group’s proprietary technology, the subject of the consent judgment Court Order from 2010 wherein BASF agreed that the process does not infringe the relevant asserted BASF patent. On March 19, 2013, the Appeal Court dismissed BASF’s appeal, reconfirming that CSI’s product Taurus SC does not infringe any relevant patent of BASF.
MANA and CSI recently became aware of a formulation mistake. Upon discovering the mistake, the companies moved quickly to audit all lots of the Taurus SC product, and confirmed that, with the exception of the two lots from Colombia, the remainder were all manufactured according to the approved process.
The product of the two lots in question was formulated in the beginning of 2012 in a single run at Makhteshim Agan Group’s subsidiary in Colombia, South America. The Colombian manufacturing facility inadvertently formulated the Taurus SC product with the incorrect fipronil technical material which was not intended to be used in products destined for the US market.
Shaul Friedland, head of MAI’s Americas region said, “We acknowledge this instance of human error, which occurred due to a temporary relocation of Taurus SC production to Colombia, while our plant in Israel was dealing with a temporary manufacturing issue and prior to the start of CSI’s Texas production. We have already verified that neither CSI nor we have any stock of product from the two lots in question. We have also asked our distributors who may still have inventory of the two lots to immediately return that product to CSI.”
CSI’s plant in Texas became ready to formulate Taurus SC as of July 2012, and all future production of fipronil material intended for the U.S. will be performed at either CSI’s plant or at MAI’s facility in Israel.