ISSUE: American Regent and FDA notified healthcare professionals of the nationwide recall of specific lots of Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL, 30 mL Multiple Dose Vial because some vials of these lots either contain particulates or have the potential to form particulates prior to their respective expiration dates.
BACKGROUND: This voluntary recall was initiated December 20, 2010 because some vials of these lots either contain particulates or have the potential to form particulates prior to their respective expiration dates. American Regent is undertaking this recall in consideration of the potential for safety issues if these lots of product are administered to patients.
RECOMMENDATION: The recalled lots are listed in the firm's press release below. Hospitals, infusion centers, clinics and other healthcare facilities should not use the drug product with these lot numbers for patient care and should immediately quarantine any product for return. As stated in the Dexamethasone Sodium Phosphate Injection, USP Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”
[12/24/2010 - Firm Press Release - American Regent]