Happi Staff10.28.20
Quimica Magna de Mexico, S.A. de C.V., Saltillo, Mexico, has been issued a warning letter by the US Food and Drug Administration (FDA) after the agency conducted testing of consumer antiseptic drug products labeled as Datsen Hand Sanitizer and Alcohol Antiseptic 62% Topical Solution Hand Sanitizer. Following an attempt to import them into the US, the Datsen Hand Sanitizer products and Alcohol Antiseptic 62% Topical Solution Hand Sanitizer products were detained and refused admission at the border.
The results of the FDA laboratory testing of batches of these products detained at the border demonstrate that the Datsen Hand Sanitizer drug products and the Alcohol Antiseptic 62% Topical Solution Hand Sanitizer drug products are adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), 21 U.S.C. 351(c). FDA said that their strength, purity, or quality falls below that which they purport or are represented to possess. In addition, the products are deemed adulterated within the meaning of section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)), in that the subpotency demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.
In addition, FDA said Datsen Hand Sanitizer and Alcohol Antiseptic 62% Topical Solution Hand Sanitizer drug products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and are misbranded under sections 502(a) and (ee) of the FD&C Act.
Datsen Hand Sanitizer, labeled to contain 75% v/v of the active ingredient alcohol (ethanol). However, FDA laboratory testing of batches of this product detained at the border found that the drug product contained only 15% ethanol v/v.
Additionally, the Alcohol Antiseptic 62% Topical Solution Hand Sanitizer contained only 50% v/v ethanol.
On June 16, 2020, FDA held a teleconference with the company and your registered US Agent, FDA Listing.com., and recommended the firm consider removing all of its hand sanitizer drug products currently in distribution to the US market. FDA said that it committed to recall all hand sanitizer drug products manufactured at your firm within expiration. However, as of the date of this letter (Oct. 15), FDA said the company had yet to initiate a recall.
On August 3, FDA notified the public of the subpotency of these hand sanitizer products.
The results of the FDA laboratory testing of batches of these products detained at the border demonstrate that the Datsen Hand Sanitizer drug products and the Alcohol Antiseptic 62% Topical Solution Hand Sanitizer drug products are adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), 21 U.S.C. 351(c). FDA said that their strength, purity, or quality falls below that which they purport or are represented to possess. In addition, the products are deemed adulterated within the meaning of section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)), in that the subpotency demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.
In addition, FDA said Datsen Hand Sanitizer and Alcohol Antiseptic 62% Topical Solution Hand Sanitizer drug products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and are misbranded under sections 502(a) and (ee) of the FD&C Act.
Datsen Hand Sanitizer, labeled to contain 75% v/v of the active ingredient alcohol (ethanol). However, FDA laboratory testing of batches of this product detained at the border found that the drug product contained only 15% ethanol v/v.
Additionally, the Alcohol Antiseptic 62% Topical Solution Hand Sanitizer contained only 50% v/v ethanol.
On June 16, 2020, FDA held a teleconference with the company and your registered US Agent, FDA Listing.com., and recommended the firm consider removing all of its hand sanitizer drug products currently in distribution to the US market. FDA said that it committed to recall all hand sanitizer drug products manufactured at your firm within expiration. However, as of the date of this letter (Oct. 15), FDA said the company had yet to initiate a recall.
On August 3, FDA notified the public of the subpotency of these hand sanitizer products.