Distribuidora Lagunera del Norte 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

Weper Clean Solutions Hand Sanitizer, which is manufactured at your facility, is labeled to contain 70% of the active ingredient alcohol (ethanol). However, FDA laboratory testing of a batch of this product detained at the border found that the drug product contained an average of only 28% v/v ethanol.

Passage 2

The subpotency of this topical antiseptic drug product 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 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, weper Clean Solutions Hand Sanitizer is labeled to contain ethanol 70%. However, FDA laboratory analyses of a batch of this product demonstrate that the product contains concentrations of ethanol that are far less than that stated on its respective product labels.

Passage 4

Weper Clean Solutions Hand Sanitizer is also misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the “FDA” logo is displayed on the product label above the National Drug Code (NDC) number, which creates the impression that the drug is approved or legally marketable

Passage 5

Further, weper Clean Solutions Hand Sanitizer is not labeled in accordance with the “Drug Facts” labeling requirements described in 21 CFR 201.66. Specifically, the product label fails to include a Drug Facts panel.

Passage 6

Lastly, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because weper Clean Solutions 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.