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Inadequate cleaning and disinfection practices has been detected in Topical otc drug products.

February 27 2025

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On February 11, 2025, the U.S. Food and Drug Administration (FDA) announced concerns regarding inadequate cleaning and disinfection practices associated with topical over-the-counter (OTC) drug products. This incident falls under the...

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On February 11, 2025, the U.S. Food and Drug Administration (FDA) announced concerns regarding inadequate cleaning and disinfection practices associated with topical over-the-counter (OTC) drug products. This incident falls under the category of "Other incident" and has been flagged for further scrutiny.

The FDA's findings indicate that certain manufacturers of these topical OTC drug products have not adhered to proper cleaning and disinfection protocols. Such practices are critical in ensuring the safety and efficacy of drug products intended for consumer use. The lack of adequate sanitation measures could potentially compromise product integrity and consumer health.

As a regulatory body, the FDA is responsible for monitoring and enforcing standards to protect public health. This incident highlights the importance of compliance with established cleaning and disinfection guidelines in the production of topical OTC drug products. The agency's ongoing investigation aims to address these deficiencies and ensure that manufacturers uphold the highest standards of quality control.

Stakeholders in the pharmaceutical industry and consumers alike should remain informed about the outcomes of this investigation, as it may impact the availability and safety of topical OTC drug products in the market.


  • Incident: Inadequate cleaning and disinfection practices has been detected in Topical otc drug products.
  • Date: 2025-02-11
  • Product: Topical otc drug products
  • Market: Available to SGS Digicomply users only. Explore the platform (for enterprises, no individual plans)
  • Hazard: Available to SGS Digicomply users only. Explore the platform (for enterprises, no individual plans)
  • Incident Category: Other incident
  • Hazard Category: null
  • Source: U.S. Food and Drug Administration

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Tags: U.S. Food and Drug Administration, Other incident, February 2025