Limpo Quimicos, 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

Andy’s Best ADVANCED HAND SANITIZER, declared to be 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 batches of this product detained at the border found that this product contained the following: an average of 1.1% ethanol v/v and an average of 63% methanol v/v; an average of 1.2% ethanol v/v and an average of 66% methanol v/v; and an average of 1.0% ethanol v/v and an average of 63% methanol v/v.

Passage 2

NeoNatural gel Hand Sanitizer, declared to be manufactured at your facility, is labeled to contain 70% v/v of the active ingredient alcohol (ethanol). However, FDA laboratory testing of this product detained at the border found that the drug product contained an average of only 32% v/v ethanol.

Passage 3

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

Passage 4

Andy’s Best ADVANCED HAND SANITIZER and NeoNatural gel Hand Sanitizer drug products are unapproved new drugs 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 5

Andy’s Best ADVANCED HAND SANITIZER is misbranded under sections 502(j), (a), (e), and (ee) of the FD&C Act, 21 U.S.C. 352(j), (a), (e), and (ee).

Passage 6

NeoNatural gel Hand Sanitizer is misbranded under sections 502(a) and (ee) of the FD&C Act, 21 U.S.C. 352(a) and (ee).

Passage 7

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 8

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.

Passage 9

The failure of this product to list methyl alcohol (methanol) as an ingredient on its label 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 10

NeoNatural gel 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.

Passage 11

Andy’s Best ADVANCED HAND SANITIZER and NeoNatural gel Hand Sanitizer are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because the products 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 are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.