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ANMAT Bans Qualibest Cleaning Line, Blocks Stolen Yectafer Lots and Orders Hessico Recall

ANMAT says these actions respond to unregistered products, stolen injectable doses with broken traceability, noncompliant manufacturing that threaten public health

Overview

  • The regulator issued the measures on Thursday, August 27, prohibiting nationwide sale, advertising and distribution of all Qualibest domisanitario products because they are being offered without valid sanitary registration or an identified habilitated establishment.
  • ANMAT ordered a nationwide ban on two Yectafer lots after Laboratorio Rontag reported the theft of 2,205 ampoules from lot 1-R0730 and 1,392 ampoules from lot 2-R0730, saying the stolen units’ storage and condition cannot be verified.
  • Rontag re‑packaged the remaining legitimate Yectafer stock with new secondary-package codes (1-R0730R and 2-R0730R) to preserve traceability while ANMAT forbids sale of the original-listed stolen lots.
  • The regulator also ordered the immediate recall of Hessico lot 29116 and opened a sanitary sumario against P. L. Rivero y Cía. S.A. after the company failed to comply with prior withdrawal orders and produced product in an unauthorized setting.
  • Consumers and health providers are urged not to use or sell the named products or lots, to keep packaging and lot numbers for verification, and to expect provincial authorities to be notified as companies pursue administrative or judicial remedies.