By Emily Field

Law360 (February 10, 2021, 8:11 PM EST ) The U.S. Food and Drug Administration has told a hand sanitizer manufacturer based in Mexico that there were multiple problems with its product, which the agency refused to allow into the country, according to a warning letter posted Tuesday.

The FDA's Jan. 28 missive to Simex Logistics SA de CV said that testing of its gel hand sanitizer at the border showed that it contained an average of about 50% ethanol, even though it's labeled as 70%. The FDA noted that the Centers for Disease Control and Prevention has recommended that consumers use an alcohol-based hand sanitizer that's no less than 60% alcohol if soap and water aren't available.

This discrepancy between the labeling and the contents renders Simex Logistics' hand sanitizer misbranded under the Food Drug and Cosmetic Act, the FDA said.

The FDA's letter came shortly after it announced that it was putting all alcohol-based hand sanitizers from Mexico on an import alert due to a sharp spike in toxic sanitizers from the country over the course of the COVID-19 pandemic.

Since the pandemic began, the FDA said there has been a rise in hand sanitizers from Mexico that test positive for methanol, otherwise known as wood alcohol, which can be toxic when it's absorbed through the skin and life-threatening if ingested.

This is the first time the FDA has issued a countrywide import alert for any drug product category, according to the agency. Under the import alert, alcohol-based hand sanitizers from Mexico are subject to higher scrutiny from the FDA and staff may detain the shipments.

According to the warning letter, the FDA and Simex Logistics had a teleconference in October and the FDA asked for more information about the company's current good manufacturing practice operations, including how it tests its finished products.

Simex Logistics responded with information on the gel makeup of its sanitizer, as well as third-party test results of the lots of sanitizer intended to be imported, the letter stated.

The third-party testing on a lot, the same one that the FDA tested, found that the formulation was variable, the FDA said.

"Specifically, the first sample from the upper layers of the bottle demonstrated subpotency (54%) and upon additional mixing of the sample bottle you obtained a result of 68%," the FDA said. "Your gel formulation does not appear to have uniform character and quality."

The company also admitted that it sent two lots to the U.S. market without finished product testing, a violation of FDA regulations, according to the letter.

Simex Logistics provided information about its own in-house testing on its drug products, the FDA said.

Its method includes using a refractometer, which measures concentrations of water-based solutions, but that isn't suitable for hand sanitizer that contains ingredients other than ethanol and water, the FDA said.

"Furthermore, you state that due to the 'antiseptic nature of the product' there is no testing performed for objectionable microbiological contamination," the FDA said. "Failure to adequately test prior to release or assure that the drug products have the identity, strength, quality and purity they purport or are represented to possess are violations of [current good manufacturing practices] requirements."

The company ultimately agreed to recall its products in November, according to the letter.

The FDA told Simex Logistics to respond with how it plans to reformulate its hand sanitizer and how it plans to improve oversight of the manufacture of its drug products.

Representatives for the company didn't immediately respond to requests for comment Wednesday.

--Editing by Regan Estes.

For a reprint of this article, please contact reprints@law360.com.