More Hand Sanitizers Stopped at the Border

The Food and Drug Administration continues to pay close attention to what’s inside hand sanitizer products coming into the US. This week the agency sent several letters to different companies from Mexico and China for adulterated products with strength, purity, or quality that fall below what is labeled on the product. 
 
A product called Instant – Hand Sanitizer – Moisturizing, manufactured by ShangRao Chunyu Technology Co., Ltd of China, was detained and refused admission at the border. The product was labeled to contain 75% of the active ingredient alcohol ethyl alcohol (ethanol), however, laboratory testing of a batch found that the drug product contained an average of only 58% ethanol volume/volume. 
 
Simex Logistics S.A. de C.V., Mexico, was also issue a warning letter related to its Health & Hand Gel Hand Sanitizer which was detained and refused admission at the border. The results of the laboratory testing found that while it was labeled to contain 70% ethanol, it contained an average of 51% ethanol volume/volume.
 
AAA Cosmetica, SA de CV, Mexico, was also flagged by FDA when its bio aaa Advance Hand Sanitizer was detained and refused admission at the border. The product was labeled to contain 70% volume/volume (v/v) of ethanol, however, FDA laboratory testing of batches found that it contained 0% ethanol and an average of 78-81% methanol v/v. 
 
Botanicals Internacional S.A. de C.V., Mexico, was issued a warning letter for its inatek Hand Sanitizer, which was detained and refused admission at the border. Labeled to contain 70% v/v of ethanol, it contained an average of 75% v/v methanol and an average of 0.2% v/v ethyl alcohol, which is 0.3% of the amount of ethyl alcohol described on the label. 
 
The warning letter sent to Precision Analitica Integral S.A. de C.V., Mexico, noted that its CleanCare nogerm Advanced Hand Sanitizer was labeled to contain 75% v/v of ethanol but contained an average of 40% ethanol v/v and an average of 28% methanol v/v.