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Argentina’s ANMAT Bans Antibiotic Lot, Pulls Two Olive Oils Over Safety and Labeling Breaches

The bans follow findings of serious quality and labeling failures.

Overview

  • ANMAT formalized the measures in the Official Gazette on Oct. 20, issuing Disposition 7695/2025 for the drug and Dispositions 7716/2025 and 7717/2025 for the olive oils.
  • The injectable antibiotic affected is Clindamicina Klonal 600 mg/4 ml, lot I2501, expiring January 2027, which showed visible particles in suspension and was classified as a major incident with medium priority.
  • Use, distribution and sale of the implicated antibiotic lot are prohibited nationwide, and Klonal S.R.L. must withdraw all units and file documentation proving recovery of the distributed stock.
  • The olive oils banned are Olivos Andinos and Olea Nativa, deemed apocryphal after provincial checks confirmed the RNE and RNPA numbers printed on their labels do not exist in official registries.
  • Food and drug authorities instructed notifications to provincial bodies, suspended online and in‑store sales, extended the ban to any product using the same false registry numbers, and advised verification through SIFeGA and return of affected units.