Endo Pharmaceuticals is voluntarily recalling two lots of Robaxin (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as “two to four tablets four times daily” rather than the…
Endo Agrees To Extend Temporary Stay Of FDA Litigation
Endo International has agreed to extend a temporary stay of its litigation against the FDA. The litigation, filed in the U.S. District Court for the District of Columbia in October 2017 by the Company’s subsidiaries, Par Sterile Products, LLC and Endo Par Innovation Company, LLC (collectively, “Endo”), seeks a declaration that FDA’s “Interim Policy” on compounding using bulk drug substances…
Endo Agrees To FDA’s Request To Seek Temporary Litigation Stay
Endo International plc has agreed to a request by the U.S. Food and Drug Administration (FDA) to seek a temporary stay of the litigation initiated against FDA in October 2017 by the company’s subsidiaries, Par Sterile Products, LLC and Endo Par Innovation Company, LLC. The litigation, filed in the U.S. District Court for the District of Columbia, seeks a…
