Grupo Yacana Mexico, S.A.S. 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

YACANA Alcohol Antiseptic 70% Topical Solution Antiseptic Hand Rub, labeled as manufactured at your facility, is labeled to contain 70% volume/volume (v/v) of the active ingredient ethyl alcohol (ethanol). However, FDA laboratory testing of one batch of this product detained at the border found that the drug product contained on average 0.04% ethanol v/v and an average of 63% methanol v/v.

Passage 2

YACANA Isopropyl Alcohol Antiseptic 70% Topical Solution Antiseptic Hand Rub, labeled as manufactured at your facility, is labeled to contain 70% (v/v) of the active ingredient Isopropyl Alcohol (IPA). However, FDA laboratory testing of a batch of this product detained at the border found that the drug product contained on average of 53% ethanol v/v and 0% (v/v) IPA.

Passage 3

YACANA Isopropyl Alcohol Antiseptic 70% Topical Solution Antiseptic Hand Rub, labeled as manufactured at your facility, is labeled to contain 70% (v/v) of the active ingredient isopropyl alcohol (IPA). However, FDA laboratory testing of a batch of this product detained at the border found that it contained 61% IPA (v/v) and 0.7% ethanol (v/v).

Passage 4

The substitution and contamination with methanol in hand sanitizer drug products labeled as manufactured in your facility, as well as the subpotency of hand sanitizer products 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 5

These topical antiseptic products are “new drugs” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a), unless they are lawfully marketed under section 505G of the FD&C Act (which is not the case for these products, as further described below).

Passage 6

YACANA Antiseptic 70% Topical Solution Antiseptic Hand Rub 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 7

The failure of this product to list methanol as an ingredient on its label also causes YACANA Antiseptic 70% Topical Solution Antiseptic Hand Rub to be misbranded under section 502(e)(1)(A) of the FD&C Act, 21 U.S.C. 352(e)(1)(A).

Passage 8

YACANA Antiseptic 70% Topical Solution Antiseptic Hand Rub and YACANA Isopropyl Alcohol Antiseptic 70% Topical Solution Antiseptic Hand Rub are misbranded under section 502(a) of the FD&C Act, 21 U.S.C 352(a), because their labeling is false or misleading.

Passage 9

YACANA Antiseptic 70% Topical Solution Antiseptic Hand Rub and YACANA Isopropyl Alcohol Antiseptic 70% Topical Solution Antiseptic Hand Rub are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because they are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and they are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.