Institute of Good Manufacturing Practices India®

Warning letter issued to Eskbiochem S.A. by USFDA, regarding the distribution of substandard and dangerous hand sanitizers.


FDA reiterates hand sanitizers comprising low levels of ethyl alcohol or isopropyl alcohol with the dangerous presence of methanol manufactured by Eskbiochem S.A. de C.V.

The USFDA claimed that certain alcohol-based hand sanitizer products have been quality compromised with the presence of harmful substances such as methanol, or wood alcohol- a toxic substance when absorbed through the skin, as well as life threatening when ingested.

The test conduct by FDA on such products proved the presence of methanol contamination ranging from one percent to 80 percent.

The FDA is proactively working with the manufacturers to recall the products and asking retailers to remove products from store shelves and online market places. The FDA is also notifying the retailers  and distributors to stop selling and distributing the product manufactured by the firm. As a part of immediate action, the FDA has also issued a warning letter to the firm regarding the distribution of product labeled as manufactured at its facilities with undeclared methanol, misleading claims- including incorrect statements about FDA approval and improper manufacturing practices.

Both substandard and dangerous hand sanitizers have been added to the alert list, preventing them to enter the US market.

The FDA authorities stated that they are extremely concerned about the serious risks of using alcohol-based hand sanitizers containing methanol. The production, import, and distribution of toxic hand sanitizer may cause serious health hazards to the public. The FDA is all set to take additional action as necessary and will continue to provide the latest information on this issue for the health and safety of consumers.