US FDA Calls And Three Mexican Firms Recall Contaminated Sanitizers, But A Fourth Hangs Up
Executive Summary
Four warnings, like previous letters FDA submitted to Mexican firms making methanol-containing hand sanitizers, which have been linked to deaths and other adverse events, indicate the targeted firms apparently entered US market for the products after the agency loosened manufacturing controls.
Recent US Food and Drug Administration warning letters to four firms in Mexico state that teleconferences prompted three to recall hand sanitizers containing undisclosed methanol while the fourth has yet to respond.
“FDA is concerned,” said the FDA Center for Drug Evaluation and Research’s offices of manufacturing quality and of compliance in a warning submitted to Grupo Insoma S.A.P.I de CV on 23 October.
The warnings published on 3 November are the latest signs of the FDA’s response to the widespread distribution of contaminated hand sanitizers made by firms in Mexico after the agency in March temporarily loosened manufacturing controls to encourage additional businesses to make the products as US consumer demand exceeded available quantities in response to the COVID0-19 pandemic.
The four warnings, like previous letters the FDA has submitted to Mexican manufacturers making methanol-containing hand sanitizers, which have been linked to deaths and other adverse events, indicate the targeted firms apparently entered the US market for the products after the agency loosened manufacturing controls.
This label is published for use in the US for hand sanitizer products fda found to contain methanol but that manufacturer grupo insoma has yet to recall.
“Your firm was recently registered as a human drug manufacturer,” the agency stated in its warning to Grupo Insoma. It made the same point in similar statements to the other three, Asiaticon SA de CV; Real Clean Distribuciones SA de CV; and 4E Global S.A.P.I. de C.V.
Millions of bottles and other containers of sanitizers made in Mexico and marketed in the US under numerous brands have been recalled since the FDA determined that multiple firms’ products contained methanol, or wood alcohol, instead of the labeled ethyl or isopropyl alcohol.
Methanol rubbed on the hands can cause dermatitis and potentially deadly systemic poisoning through transdermal absorption.
Grupo Insoma, however, apparently isn’t convinced it should recall the sanitizers it made that are available in the US and have been found to contain methanol, according to the FDA’s warning. Its product, identified as “Hand Sanitizer Gel Unscented 70% Alcohol 1000Lts,” remains available in the US.
The warning states CDER officials on 29 June conducted a teleconference with Grupo Insoma, of Cuanutitlan, and its US agent, CIRG Waste & Recycling Solutions U.S. LLC. “We recommended you consider removing your firm’s hand sanitizer drug products currently in distribution in the U.S. market,” the officials stated.
CIRG Waste & Recycling, of Brownsville, TX, agreed with CDER officials in a 5 August teleconference to recall all of Grupo Insoma’s hand sanitizer drug products currently in distribution in the US. “However, your US agent later sent an email on August 6, 2020, stating that he reached out to you and that he needed to get your firm to recall,” the letter states.
One, Sometimes Two Calls Needed
The other firms warned in the recently published letters also were contacted by CDER officials via teleconference about recalling their products. Each of those complied with the agency’s recommendation, although one, Real Clean Distribuciones, apparently isn’t the source of all the contaminated sanitizers that its US agent, G Mason Group LLC, is distributing, according to the warnings.
asiaticon is recalliing all lots of its v-klean hand sanitizer gell distributed in the us.
Real Clean Distribuciones was contacted by CDER officials on 14 July about contaminated Born Basic and Scent Theory brand hand sanitizers and nine days later announced it would “recall only those batches manufactured by your firm in Mexico,” according to the warning submitted on 27 October to the firm in Tlalnepantla de Baz.
The letter doesn’t state whether the agency has contacted other manufacturers providing contaminated Born Basic and Scent Theory brand hand sanitizers Mason Group, located in New York City, is distributing.
In a 23 October warning, CDER officials stated they needed two teleconferences to convince 4E Global to recall all lots of its Advanced Instant Hand Sanitizer Clear Ethyl Alcohol 70% and blumen Clear Advanced Hand Sanitizer Extra Soft. Officials recommended a recall in a 6 July teleconference with the firm in Tultitlan, and with its US agent, Registrar Corp., of Hampton, VA.
The letter states 4E Global on 11 July 11 “agreed to recall certain lots of hand sanitizers that were distributed in the US” but it took a second call from CDER officials nine days later before on 24 July it expanded “the scope of the recall to include all hand sanitizer products within expiry that were distributed in the US market due to potential presence of” methanol.
Asiaticon announced its recall of V-Klean Hand Sanitizer Gel on 25 August, 20 days after its teleconference with CDER officials, according to the center's 29 October warning. The firm in Tlalpanis recalling all lots of its product identified as containing methanol.
How'd This Happen?
Each of the firms, including Grupo Insoma even though it has yet to recall its products, was instructed by CDER officials to respond by conducting a “detailed investigation into how hand sanitizer drug products” manufactured at its facility and labeled as containing ethanol “were substituted in part or in whole with methanol.”
The agency also asks each firm for lists of all raw materials used to manufacture all of its hand sanitizers, including the suppliers’ names, addresses, and contact information, and of all batches of any hand sanitizer products it shipped to the US with “a full reconciliation of all material you distributed.” The firms also were instructed to submit copies of complete records for all batches distributed to the US.
The four firms’ products were identified as unapproved new drugs and misbranded drugs due to the presence of methanol, and each was warned about good manufacturing practices violations for allowing the substance to enter its production process.
The FDA opened wider the door for entry into the US hand sanitizer market in March with three temporary guidances on preparing or compounding alcohol-based hand sanitizer products, on manufacturing alcohol for those products and on denaturing alcohol in sanitizers. (Also see "US Consumers' Hand Sanitizer Resources Expand: FDA Allows Compounding During Pandemic" - HBW Insight, 18 Mar, 2020.)
However, problems quickly surfaced in products made by the more than 1,500 businesses that acted on the agency’s encouragement, including noncompliant labels, formulations and claims. (Also see "Hand Sanitizers Offered In Liquor Bottles Among Emerging Concerns Under US FDA's Pandemic Rule" - HBW Insight, 27 Apr, 2020.)
The appearance of methanol-containing sanitizers in the US compelled the agency in August update the three temporary guidances to prevent the use of alcohol ingredients other than ethyl or isopropyl in the products and to emphasize denaturing alcohol used for sanitizers. (Also see "US FDA Clarifies Testing In Sanitizer Production Temporary Guidances To Tighten Compliance" - HBW Insight, 10 Aug, 2020.)
Additionally, the prevalence of contaminated hand sanitizers imported into the US led the FDA to create an import alert category to block the products from reaching the country. (Also see "US FDA Adds Hand Sanitizer Import Alert Category After COVID-19 Production Surge Turned Deadly" - HBW Insight, 18 Sep, 2020.)