Overview

• Disposición 6199/2025 published in the Boletín Oficial halts production at Laboratorios P. L. Rivero y Cia. S.A. and bans nationwide the 0.9% sodium chloride 500 ml lots 70413108 and 70416108 expiring December 2027, with an immediate market recovery order.
• The measure followed a March 11 notification that sachets of saline were leaking, after which INAME recommended closure of the facility and the opening of administrative summaries.
• Inspections since January 2022 documented unresolved Good Manufacturing Practices violations, including lack of continuous particle monitoring equipment, absent air‑sampler documentation, and manual dosing by under‑qualified operators in critical areas.
• ANMAT categorized the deficiencies as critical and said the safety and efficacy of affected products cannot be assured, though authorities noted no victims have been reported.
• The enforcement action reflects intensified scrutiny of sterile‑product manufacturers following the contaminated‑fentanyl crisis that heightened concerns over medicine safety.