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[SITUATION] · [ACTIVE] · [HEALTH]

3 clusters · 19 sources · 29 days · First seen · Last updated

Cofepris medication safety alerts in Mexico

Overview

Mexico’s Federal Commission for Protection against Sanitary Risks (Cofepris) has issued multiple health alerts regarding the presence of falsified, adulterated, and counterfeit medications in the country.

Initial alerts identified irregularities in widely used products including Saizen, Bedoyecta, Buscapina Compositum, and Granulox. Specific issues included failed sterility tests, lack of official distribution records, altered expiration dates, and non-existent packaging formats. Cofepris noted that the safety, quality, and efficacy of these products could not be guaranteed due to unknown manufacturing and storage conditions.

Subsequent alerts expanded the scope to include adulterated oral solutions, such as ADerogyl, which lacked expiration dates on certain ampoules. Additionally, counterfeit versions of specialized medications were identified, including Darzalex for bone marrow cancer and Simponi for rheumatoid arthritis. In these cases, manufacturers reported that certain batch numbers had no official manufacturing or release records.

Recent updates have intensified the focus on Saizen 20 mg, an injectable somatropin used for growth disorders. Merck Biopharma Distribution identified several irregular batches, including lot BA054637, which showed a modified expiration date and failed sterility tests, and lots BA010812 and KW010374, which failed sterility tests and were not distributed by the authorized company. Further counterfeit Saizen lots, such as EC179361, BA088217, and AB003660, have also been flagged. Authorities advise the public to avoid informal sources like street markets or unverified online platforms.

Entities

Cofepris · Sanofi Aventis de México · Mexico · Bedoyecta · Instituto de Salud Pública

Timeline

  1. [HEALTH] 2 sources
    Cofepris issues alert over counterfeit Saizen growth hormone

    Mexico's Cofepris has warned against counterfeit Saizen (somatropin) growth hormone batches, citing issues with sterility and unauthorized distribution of several specific lot numbers.

  2. [HEALTH] 3 sources
    Cofepris issues alerts for adulterated and counterfeit medications in Mexico

    Cofepris has issued alerts in Mexico regarding adulterated ADerogyl and counterfeit Darzalex and Simponi medications, warning that their purity and efficacy cannot be guaranteed.

  3. [HEALTH] 15 sources
    Cofepris issues health alerts for falsified medications in Mexico

    Mexico's Cofepris has issued health alerts for falsified or adulterated versions of Saizen, Bedoyecta, Buscapina Compositum, and Granulox, warning of unknown safety and efficacy risks.

Sources

acierta.mx · almomento.mx · codigoqro.mx · consultorsalud.com · diarioevolucion.com.mx · elbuentono.com.mx · eltiempomx.com · estamosaqui.mx · laregiontula.com.mx · laverdadnoticias.com · massinformacion.com.mx · ncscampeche.com · noticiasnrt.com · nuevolaredo.tv · pensadorqueretano.com · plazajuarez.mx · tribuna.com.mx · vanguardia.com.mx · xeu.mx

This summary has been updated 1 time: see revision history