Incredible Products, SA de CV

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 this product contained an average of 1.2% ethanol and 67% methanol v/v. Therefore, this hand sanitizer drug product is adulterated under section 501(d)(2) of the FD&C Act in that the active ingredient, ethanol, was substituted wholly or in part with methanol, a dangerous chemical when in contact with human skin or ingested.

Passage 2

The substitution and contamination with methanol in a drug product labeled as manufactured in your facility demonstrates that the quality assurance within your facility is not functioning in accordance with CGMP requirements under section 501(a)(2)(B) of the FD&C Act.

Passage 3

This topical antiseptic product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling.

Passage 4

GELBACT ANTIBACTERIAL HAND GEL does not conform to the 1994 TFM, as further amended by the 2016 Consumer Antiseptic Rubs Proposed Rule, nor any other TFM, proposed rule, or final rule, and does not meet the conditions under section 505G(a)(3) of the FD&C Act, for marketing without an approved application under section 505.

Passage 5

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 6

GELBACT ANTIBACTERIAL HAND GEL is labeled to contain ethyl alcohol 80%. However, FDA laboratory analysis of a batch of this product demonstrate that the product contains a concentration of ethyl alcohol (ethanol) that is less than what is stated on the product label and contains a significant concentration of methyl alcohol (methanol), an ingredient that is not declared on the product label.

Passage 7

The failure of this product to list methyl alcohol (methanol) as an ingredient on its label causes 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 8

GELBACT ANTIBACTERIAL HAND GEL is misbranded under section 502(x) of the FD&C Act, 21 U.S.C. 352(x), because the product labels fails to disclose a 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 GELBACT ANTIBACTERIAL HAND GEL 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.