Particle.news
Download on the App Store

ANMAT Revokes Four Lab Licenses and Bans Unregistered Cosmetics and an Injectable Antibiotic

Inspections uncovered unregistered products alongside critical GMP failures, prompting bans, recalls, preventive shutdowns.

Overview

  • Four pharmaceutical establishments—Weltrap, Carter Pack, Incaico and Pacemaker—lost their sanitary habilitation for operating without a qualified technical director under national health law and ANMAT standards.
  • ANMAT barred all lots of the injectable antibiotic DANFERANE I.V. (trimethoprim 80 mg + sulfamethoxazole 400 mg; Cert. No. 43.621) from P.L. Rivero y Cía. S.A. after a REM check refuted a claimed alternative manufacturer authorization, with INAME rating inspection findings as critical.
  • The agency ordered a preventive inhibition of P.L. Rivero’s production and opened an administrative investigation following deficiencies that could compromise product quality, safety and efficacy.
  • Unregistered cosmetic products—gels and base creams sold under Quifam, Vepo, Ecotidy, Activa Lab and Nameco—were prohibited nationwide after cosmetovigilance found listings on Mercado Libre; the order covers use, sale, promotion and distribution across all lots.
  • ANMAT also inhabilitated LADECE S.A. following grave irregularities that included unauthorized products, missing production records and improper recalls, with measures published in the Official Gazette and enforcement notifications issued to provincial regulators and online marketplaces.