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October 27, 2025
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Minsa identifies contaminated batch of Edetoxin as the origin of outbreak due to Ralstonia pickettii bacteria

Minsa identifies contaminated batch of Edetoxin as the origin of outbreak due to Ralstonia pickettii bacteria

He Ministry of Health (Minsa) identified a contaminated batch of the drug Edetoxin 200 mcg/2 mL as the origin of outbreak of hospital infections caused by environmental bacteria Ralstonia pickettiiwhich affected 28 patients in six establishments in Metropolitan Limamainly in the National Institute of Child Health (INSN) San Borja.

The finding was confirmed by the National Center for Epidemiology, Disease Prevention and Control (CDC) through the Epidemiological Alert AE–CDC No. 006-2025after verifying that all cases were linked to a batch of the sedative imported by Nordic Pharmaceutical Company SAC and made in india.

He National Institute of Health (INS) detected on October 22 the presence of Ralstonia pickettii in a vial of the lot ABO25001which led to the national immobilization of the product and the temporary closure of the importing company’s premises.

Vulnerable patients and rapid response

Among the affected patients were 13 minors with complex congenital heart diseasein addition to immunocompromised adults, premature babies, people with cancer and dialysis patientsThe Minsa specified that There have been no deaths directly attributable to the infection.since the reported deaths are related to the underlying diseases.

The General Directorate of Medicines, Supplies and Drugs (Digemid) reported that recovered more than 84% of the distributed bottles of the contaminated batch in the first hours of intervention.

Legal actions and health control

During a visit to the INSN San Borja, the Minister of Health, Luis Quirozannounced that, by order of the Presidency of the Republic, Nordic Pharmaceutical Company was suspended from all activitieswhile they start legal actions against those responsible.

We would not be able to hide information. We would be putting people’s lives at risk and we are not going to do that.”he declared Luis QuirozMinister of Health.

The head of the sector emphasized that the Minsa acted with transparency and speed to contain the outbreak and reinforce the national health surveillance.

The bacteria and its risks

According to the Minsa, the Ralstonia pickettii it’s a bacteria low virulence environmental that does not represent community riskbut it can affect hospitalized patients in critical condition.His ability to survive in medical solutions and pass through sterile filters has raised concern about the quality controls of imported medicines.

Control and surveillance measures

He CDC Peru instructed all public and private health facilities to:

  • Report suspicious cases within a maximum period of 24 hours.
  • Reinforcement of hand hygiene and aseptic handling of medications.
  • Avoid sharing or fractional use of single-use vials.
  • Send isolated strains to the INS for the analysis of antimicrobial resistance.

Import standards review

Minister Quiroz announced that the Minsa will review the Authorization criteria for imported medicinessince the Indian laboratory that manufactures Edetoxin does not have certification in good manufacturing practicesdespite maintaining current authorizations for other products.

The Ministry announced that the epidemiological alert will remain active until the investigations are concluded and it is ensured that no contaminated batch reaches health services.

Key data

  • Medication involved: Edetoxin 200 mcg/2 mL
  • Identified bacteria: Ralstonia pickettii
  • Confirmed cases: 28 patients in Metropolitan Lima
  • Hospitals affected: 6, including INSN San Borja
  • Contaminated lot: ABO25001
  • Importing company: Nordic Pharmaceutical Company SAC
  • Product origin: India
  • Product recall rate: 84%
  • Sanitary measure: National immobilization and suspension of the company
  • Minister of Health: Luis Quiroz
  • Epidemiological alert: AE–CDC No. 006-2025

Frequently asked questions

What medication caused the outbreak of infections?

The sedative Edetoxin 200 mcg/2 mL, lot ABO25001.

What bacteria was detected?

The Ralstonia pickettiia low-virulence environmental bacteria.

How many patients were affected?

28 people, mainly minors and immunocompromised patients.

Are there deaths from the infection?

No deaths directly attributable to the bacteria have been reported.

What measures did the Minsa adopt?

It immobilized the medicine, suspended the importing company and activated a national health alert.

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