American Regent has initiated the voluntary recall because some vials of this lot were observed to be slightly discolored and upon standing have the appearance of sediment on the bottom of the vials.
American Regent has warned hospitals, infusion centers, clinics and other healthcare facilities not to use its Magnesium Sulfate injection, USP, Lot no 0491, for patient care and to immediately quarantine any product for return.
American Regent president and CEO Mary Jane Helenek said that patient safety is their primary concern, and they were committed to taking the necessary steps to protect patients from any potential safety risks.
American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the agency.
Magnesium Sulfate injection, USP is manufactured by Luitpold Pharmaceuticals and is distributed by American Regent.