MYM Hidrominerales 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

FDA laboratory testing of a batch of this product detained at the border found that the drug product contained on average 0.05% ethanol and an average of 79% methanol v/v.

Passage 2

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

Passage 3

Protz real protection ANTIBACTERIAL HAND SANITIZER is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) 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

this hand sanitizer is misbranded under section 502(a) of the FD&C Act, 21 U.S.C 352(a), because its labeling is false and misleading.

Passage 6

The failure of this product to list methyl alcohol (methanol) as an ingredient on its label also causes it to be misbranded under section 502(e)(1)(A) of the FD&C Act, 21 U.S.C. 352(e)(1)(A).

Passage 7

Protz real protection ANTIBACTERIAL HAND SANITIZER is also misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C.352(f)(2), because the product label does not include all of the applicable warnings as required under 21 CFR 330.1(g).

Passage 8

Protz real protection ANTIBACTERIAL HAND SANITIZER is misbranded under section 502(x) of the FD&C Act, 21 U.S.C. 352(x), because the product’s label fails to disclose a complete domestic address or domestic telephone number through which the responsible person may receive a report of a serious adverse event with such drug.

Passage 9

this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because Protz real protection 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 and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.