Albek de Mexico S.A. de C.V.

Selected passages from the FDA letter

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

Passage 1

the active ingredient, ethanol, was substituted wholly or in part with methanol

Passage 2

in that the substitution demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements

Passage 3

this product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act

Passage 4

It is misbranded under section 502(j) of the FD&C Act, 21 U.S.C. 352(j), because it is dangerous to health when used according to its labeling as a hand sanitizer

Passage 5

The failure of this drug product to list methyl alcohol (methanol) as an ingredient on its label causes it to be misbranded under section 502(e)(1)(A)

Passage 6

this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section