Overview

• The action was formalized in Disposición 6199/2025 published in the Boletín Oficial on August 29.
• ANMAT prohibited the use, commercialization and distribution nationwide of 0.9% sodium chloride 500 ml lots 70413108 and 70416108 with December 2027 expiry.
• ANMAT/INAME had notified the firm on March 11 of a presumed quality deviation after reports that 500 ml saline sachets from lots 70313108 and 70413108 were losing solution.
• INAME’s Directorate of Oversight and Risk Management recommended opening summary proceedings in addition to the preventive shutdown.
• Inspection records detail unresolved critical deficiencies including missing continuous particle monitoring, inadequate air sampling, manual dosing in blood-bag filling, weak validation and maintenance programs, and substandard sterile-area design at the Buenos Aires plant.