The national Administration of Medicines, Food and Medical Technology (ANMAT) ordered the prohibition of the use, marketing and distribution throughout the national territory of two products manufactured by the company HLB Pharma Group SA, after detecting a serious incident of mix-up (cross contamination) between blisters of Sodium diclofenac y Morphine.
The measure was taken after a complaint received by the Administration, which resulted in a series of investigations and actions by the National Institute of Medicines (INAME). According to official information, a categorized quality diversion was found as criticalwhich represents a Public health risk.
The products involved are:
-- DICLOFENAC HLB / DICLOFENAC SodiumCertificate No. 52,922, Lot 80020, in presentation of unauthorized plastic ampoules.
- Morphine at 1% HLB / MorphineCertificate No. 43,292, Lot 31050.
Both lots were being voluntarily removed from the market by the firm since October 2024, however, despite having elapsed more than 120 days since the beginning of the process, The company failed to recover all distributed unitswhich motivated Anmat’s intervention.
In an interview conducted in October last year, authorities of the Ina They had instructed the company to immobilize all small -volume parenteral products that would not have authorized container. However, persistent breaches were detected in current regulations.
The provision, signed by the National Administrator of ANMATalso orders HLB Pharma Group S.A. which ends the withdrawal of the market from the mentioned products and present the corresponding support documentation before the Department of Post Marketing Surveillance.
