What happened
Original notice title
AriBio H&B Co., Ltd. MARCS-CMS 613107, October 08, 2021
From the archived source record
The results of the FDA laboratory testing of a batch of this product detained at the border demonstrate that this drug product labeled as manufactured at your facility is adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), 21 U.S.C. 351(c), in that its strength, purity, or quality falls below that which it purports or is represented to possess. In addition, this product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), in that the subpotency, in addition to the deficiencies in your response to the information we requested during the November 20, 2020 teleconference, demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements. In addition, Hand Sanitizer Original drug product is misbranded under sections 502(a) and (x) of the FD&C Act, 21 U.S.C. 352(a) and (x). These violations are described in more detail below. Adulteration Violations Hand Sanitizer Original, labeled as manufactured at your facility, is labeled to contain 70% weight by volume (w/v) of the active ingredient anhydrous ethanol (ethanol). This hand sanitizer drug product is adulterated under section 501(c) of the FD&C Act in that the active ingredient of ethanol is present at levels in the products lower than that which is declared on their labeling. We requested additional information concerning your CGMP operations, including test methods for your finished drug product, active ingredient supplier information, a statement confirming that you follow drug CGMP per 21 CFR Parts 210 and 211, and your investigation into the subpotent batch tested by FDA. Uses: Hand sanitizer to decrease bacteria on the skin that could cause disease . . . rub into the skin until dry.” Hand Sanitizer Original is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because its label contains statements that are false or misleading.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 3a5817c9a286
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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