Sck Zeta Dis Ticaret, Pazarlama Ltd.

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 63% v/v ethanol and an average of 6% 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 demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.

Passage 3

your NEUTREVO Instant Hand Sanitizer is unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a)

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 or misleading. As noted above, NEUTREVO Instant Hand Sanitizer is labeled to contain alcohol 70%. However, FDA laboratory analysis of a batch of this product demonstrates that the product contains a concentration of ethyl alcohol (ethanol) that is less than what is stated on the product label and contains methyl alcohol (methanol), an ingredient that is not declared on the product label.

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). This product is misbranded under 502(e)(1)(A) because the product does not list the established name of each active and inactive ingredient, as required by 21 CFR 201.66(c)(2) and (8), and the quantity of each active ingredient, as required by 21 CFR 201.66(c)(2).

Passage 7

this product is misbranded under section 502(x) of the FD&C Act, 21 U.S.C. 352(x), because the product label 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 8

This product is further misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because the product’s Drug Facts panel contains extraneous information that goes beyond the required warnings described in the final rule. See also 21 CFR 201.66(d)(7) ( stating that additional information not described in the content requirements for OTC drug products shall not appear in the Drug Facts panel). The “Ingredients” section of the Drug Facts panel of your products includes extraneous statements such as “Hygienic antibacterial hand cleaning gel which is effective against bacteria that does not require water and towels.”

Passage 9

this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because NEUTREVO Instant 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.