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ANMAT Issues New Nationwide Bans, Halts Filaxis After GMP Failures

The regulator published fresh Boletín Oficial dispositions citing falsified labels, lost traceability plus critical manufacturing breaches to protect public health.

Overview

  • Disposición 6843/2025 preventively inhibited Filaxis Farmacéutica S.A. in San Isidro and ordered the withdrawal of eight lots of Oxaliplatino 100 mg and Docetaxel 20 mg following inspections that found critical Good Manufacturing Practices deficiencies.
  • Disposición 6776/2025 prohibited 13 Juka Alisados hair products lacking sanitary registration, with ANMAT warning that unregulated straighteners may contain formaldehyde and pose ocular, respiratory and carcinogenic risks.
  • Disposición 6779/2025 banned the unregistered product “Lavandina en Polvo Calitex,” which was sold online without an identified manufacturer, and suspended its production, sale, distribution and advertising nationwide.
  • Disposición 6781/2025 outlawed home water treatment devices and replacement filters from brands including gowave, Water Purifier, Water Fusion, Agoa home, Pentair, Osvan and Electrolux after user complaints and verification of missing registrations and improper labeling.
  • Further actions included Disposición 6780/2025 against the illegitimate pet product “Chau Pis” for an apocryphal RNE and Disposición 6777/2025 targeting Medical Team S.R.L. over high‑risk medical devices with falsified labels, with provincial authorities notified to enforce withdrawals and initiate administrative proceedings.