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Customs agents seize 10,000 unapproved N-95 respirator masks

Agents say they have continued to seize unapproved COVID-19 equipment and medications in Baltimore, Harrisburg, Philadelphia, and other ports
Credit: U.S. Customs and Border Patrol

BALTIMORE — U.S. Customs and Border Protection announced Friday that officers in Philadelphia seized 10,000 unapproved KN-95 respirator masks Thursday, and have continued to seize unapproved COVID-19 medications and related products.

Officers initially examined a shipment of 10 boxes from Israel on May 15 and observed respirator masks that appeared to be of poor quality and packaging, the CBP said. 

The masks, which were manufactured in China, were destined to an address in Philadelphia. 

Officers detained the shipment and consulted with U.S. Food and Drug Administration inspectors, who determined that the shipment violated the Federal Food, Drug, and Cosmetic Act, which prohibits the importation of adulterated or misbranded food, drugs, devices, tobacco products, or cosmetics. 

The manufacturer is also not registered with FDA and does not have an Emergency Use Authorization to import the KN-95 masks, the CBP said.

In addition to these 10,000 unapproved KN-95 face masks, CBP officers at Ports of Entry across the Baltimore Field Office continue to seize shipments of counterfeit and unapproved coronavirus personal protective equipment and pharmaceuticals.

Since May 16, officers at the Area Ports of Philadelphia, Baltimore and Washington, and the Ports of Harrisburg, Pittsburgh and Wilmington, Del., in consultation with FDA inspectors, completed 12 seizures that collectively included:

  • 25 unapproved and counterfeit COVID-19 test kits;
  • 10 other counterfeit N95 respirator masks;
  • more than 2,300 Lianhua Qingwen Jiaonang capsules;
  • more than 700 additional tablets, pills, capsules, and sachets of unapproved medicines, including Hydroxychloroquine, Oseltamivir, Zithromax, Panadol, and unknown medicines;
  • nearly 4,000 doses of Huoxiang Zhengqi dripping pills, an unproven herbal cold remedy; and
  • nine packages of Virus Shut Out lanyards

These products are not on the current Emergency Use Authorization List nor are the manufacturers on the list of firms who have provided compliance notification to the FDA. As such, the products are inadmissible to the United States for violating the Federal Food, Drug, and Cosmetic Act.

CBP is withholding specific details of individual seizures as many cases remain under investigation.

“Predatory scammers continue to prey on consumer fear by peddling these counterfeit or unapproved and potentially dangerous products as legitimate COVID-19 protective equipment or medicines,” said Casey Durst, CBP’s Director of Field Operations in Baltimore. “Customs and Border Protection officers will continue to work with our consumer safety partners to identify and seize products that could potentially harm American consumers.”

These products were shipped from manufacturers and distributors in China, Hong Kong, Nigeria, UAE and the United Kingdom and were destined to addresses in Florida, Pennsylvania, and Virginia.

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