Drugs

FDA Finds Multiple Violations in Mexican Hand Sanitizers

FDA says its testing of Bersih hand sanitizers manufactured by Soluciones Cosmeticas, Mexico City, Mexico, determined that batches of the products were adulterated by including methanol with the ethanol active ingredient. An 8/4 Warning Letter also says the products are unapproved misbranded new drugs.

The letter says the firm agreed to recall all of its hand sanitizer products and verified that the products were refused admission to the U.S.

The company was told to provide:

a detailed investigation into how hand sanitizer drug products manufactured at the company’s facility and labeled as containing ethanol were substituted in whole or in part with methanol;
a list of all raw materials used to manufacture all of the company’s hand sanitizer drug products with suppliers’ names, addresses, and contact information;
a list of all batches of any hand sanitizer drug products shipped to the U.S. by Soluciones and a full reconciliation of all material distributed; and
copies of the complete batch records for all batches distributed in the U.S.

FDA says the firm’s hand sanitizers are unapproved new drugs and do not conform to a 1994 tentative final monograph, a 2016 consumer antiseptic rub proposed rule, a 2015 health care antiseptic proposed rule, or any other tentative final monograph or final rule, and also do not meet conditions in the 2020 CARES Act for marketing without an approved application.

The agency placed all drugs and drug products manufactured by Soluciones on Import Alert 7/10. The company was told to respond with a list of specific actions taken to correct the violations and prevent their recurrence, with a schedule for completing the actions.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome