Health License Revoked for SAFE, a PiSA Farmacéutica Subsidiary, After Bacterial Outbreak Causes Death of 13 Children in the State of Mexico

The Federal Commission for the Protection Against Sanitary Risks (Cofepris) has revoked the health license of Productos Hospitalarios S.A. de C.V., commercially known as SAFE and a subsidiary of PiSA Farmacéutica, due to its alleged involvement in a Klebsiella oxytoca outbreak that resulted in the deaths of 13 children in the State of Mexico in late 2024.

The decision followed an inspection carried out in December 2024, which uncovered irregularities at SAFE’s facility in Toluca. This plant was responsible for producing total parenteral nutrition (TPN) intravenous solutions, used to feed patients who are unable to eat by mouth.

Investigations suggest that these solutions may have been contaminated with Klebsiella oxytoca, a bacterium resistant to multiple antibiotics and capable of causing severe infections in immunocompromised patients.

Between 2003 and 2021, SAFE secured nearly 1,500 federal and state contracts totaling approximately 17 billion pesos, supplying medical inputs to various healthcare institutions across the country.

President Claudia Sheinbaum expressed concern over the outbreak and emphasized that the top priority is to support the affected families. A nationwide epidemiological alert has been issued, and production of SAFE’s medical solutions was suspended as of November 21, 2024.

Although health authorities continue to investigate the exact cause of the outbreak, no traces of the bacterium have yet been found at SAFE’s facility.
Nevertheless, the revocation of its health license remains in place as a precautionary measure to prevent further public health risks.

This case highlights the critical importance of maintaining strict health and safety controls in the production of medical supplies especially those intended for vulnerable populations such as newborns and immunocompromised patients.