Particle.news

ANMAT Orders Immediate Withdrawal as Rigecin Labs Recalls Multiple Injectable Lots

The regulator cites suspected quality deviations tied to potential packaging breaches.

Overview

  • Rigecin Labs began a voluntary market withdrawal after ANMAT issued an urgent alert on November 26.
  • The recall covers Ringer Lactate (lot RL2096 S1, expiring 04/2027), sterile water for injectables/irrigation (lots HO4122/HO4123/HO4124 S1), and 0.90% isotonic saline (lots NA5187 S1, NA5675 S2, NA5694 S1/S2, NA5801 S1/S2, NA5804 S1/S2, NA5805 S1/S2) with expirations in 01/2027 and 04/2027.
  • ANMAT activated its recall protocol, reinforced oversight, and is tracking product removal to mitigate public‑health risk.
  • Pharmacies, hospitals, and clinicians were told to pull the listed lots from circulation, refrain from use, and report any remaining stock; the public was advised to avoid affected units.
  • Coverage notes a developing concern about possible microbiological contamination, which remains under investigation.