06/23/2020

06/17/2020

KBMO Diagnostics, LLC

Center for Devices and Radiological Health

Adulterated and Misbranded Products Related to Coronavirus Disease 2019

06/23/2020

06/17/2020

BHP Holdings Inc. dba BioPure Healing Products

Division of Human and Animal Food Operations West VI

CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated

06/23/2020

06/12/2020

Nanobots Healthcare, LLC dba Assurance Infusion

Division of Pharmaceutical Quality Operations II

Compounding Pharmacy/Adulterated Drug Products

06/23/2020

06/12/2020

Rapid Equine Solutions, LLC

Division of Pharmaceutical Quality Operations I

Animal Drugs/Adulterated

06/23/2020

06/08/2020

Diamond Rock Food Imports Inc.

Division of Northeast Imports

Foreign Supplier Verification Program (FSVP)

FDA Maintains the Pace of Meeting Its Goals on Applications for Medical Products During the Pandemic

One of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the timely reviews of medical product applications despite a surge in volume of work and practical constraints that may impact our ability to conduct on-site inspections. The public counts on the FDA to review and, when appropriate, to approve or clear medical products that are so important to patients and health care providers. I am pleased to announce today that the FDA has maintained the same pace of meeting its goals on review of applications for medical products during the pandemic that it has maintained in recent years. For instance, we are currently on target to meet our user fee goals for drugs this year by reviewing and taking timely action on at least 90% of brand, generic, and biosimilar drug applications even during the pandemic.

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Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/good-manufacturing-practice-considerations-responding-covid-19-infection-employees-drug-and?utm_campaign=CDER%20New%2006%2F22%2F2020&utm_medium=email&utm_source=Eloqua&elqTrackId=82f5e7c0db044780978f498bd4b415e4&elq=74bd5535797240f0b579c71cd1579272&elqaid=13041&elqat=1&elqCampaignId=11113

FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem

[6/19/2020] FDA advises consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol (wood alcohol), a substance that can be toxic when absorbed through the skin or ingested. FDA has identified the following products manufactured by Eskbiochem:

• All-Clean Hand Sanitizer (NDC: 74589-002-01)
• Esk Biochem Hand Sanitizer (NDC: 74589-007-01)
• CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-008-04)
• Lavar 70 Gel Hand Sanitizer (NDC: 74589-006-01)
• The Good Gel Antibacterial Gel Hand Sanitizer (NDC: 74589-010-10)
• CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-005-03)
• CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-009-01)
• CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-003-01)
• Saniderm Advanced Hand Sanitizer (NDC: 74589-001-01)

FDA tested samples of Lavar Gel and CleanCare No Germ. Lavar Gel contains 81 percent (v/v) methanol and no ethyl alcohol, and CleanCare No Germ contains 28 percent (v/v) methanol. Methanol is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects.

Consumers who have been exposed to hand sanitizer containing methanol should seek immediate treatment, which is critical for potential reversal of toxic effects of methanol poisoning. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

On June 17, 2020, FDA contacted Eskbiochem to recommend the company remove its hand sanitizer products from the market due to the risks associated with methanol poisoning. To date, the company has not taken action to remove these potentially dangerous products from the market. Therefore, FDA recommends consumers stop using these hand sanitizers and dispose of them immediately in appropriate hazardous waste containers. Do not flush or pour these products down the drain.

FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol.

FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. Additionally, the agency is concerned with false and misleading claims for hand sanitizers, for example that they can provide prolonged protection such as 24-hours against viruses including COVID-19, since there is no evidence to support these claims.

To date, FDA is not aware of any reports of adverse events associated with these hand sanitizer products. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.