FDA WARNING_LETTER - Soluciones Cosmeticas, SA de CV - August 04, 2020

The FDA issued a Warning Letter to Soluciones Cosmeticas SA de CV, a registered human drug manufacturer, following the detention and refusal of admission of their BERSIH Antiseptic Alcohol 70% Topical Solution Hand Sanitizer and BERSIH HAND SANITIZER GEL products into the U.S.

FDA testing revealed that BERSIH Antiseptic Alcohol 70% Topical Solution Hand Sanitizer, labeled to contain 70% ethanol, contained an average of 44% ethanol and 30% methanol. BERSIH HAND SANITIZER GEL, also labeled for 70% ethanol, contained 67% ethanol and 1.6% methanol. These products are adulterated under section 501(d)(2) of the FD&C Act due to the substitution of ethanol with toxic methanol, and under 501(a)(2)(B) for demonstrating a non-functioning quality assurance system.

The products are also unapproved new drugs under section 505(a) and misbranded under sections 502(j), (a), and (e) of the FD&C Act. They are dangerous due to methanol, falsely labeled regarding ethanol content, and fail to declare methanol as an ingredient.

The firm was notified on July 1, 2020, and subsequently agreed to a nationwide recall of BERSIH HAND SANITIZER GEL on July 14