FDA warning letter · Drugs

Genesis Partnership Company SA

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your Bathletix HAND SANITIZER product is packaged in containers that resemble drinking water bottles customarily purchased by U.S. consumers. OTC hand sanitizer drug products packaged in containers that resemble beverage containers commonly used by adults and children may mislead consumers into believing the products are food and, thereby, increase the risk of accidental ingestion.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.128